Meet the Founder of iSMART, Sue D’Arcy on our latest Q&A: 

From a chance discovery in hospital cancer wards to safe, clinical-grade devices you can use at home – the personal mission that’s been driving us for over 25 years.

Q1. Sue, can you tell us a little about your background and your earlier days working with light therapy?

My background is in biochemistry, and I also hold an MBA. I’ve been working with LED technology for around 25 years now, starting out with the professional models that were used in hospitals and doctors’ clinics.

I love telling the story of how light therapy was first discovered for skin rejuvenation, it wasn’t even what it was originally intended for! LED therapy was initially used in hospitals to treat non-melanoma skin cancers. Doctors noticed that the skin surrounding the treated area was also improving, it looked healthier, smoother, more youthful. That observation led to the very first study on LED therapy for skin rejuvenation, which showed incredible results. Since then, LED has continued to grow in the medical field, becoming one of the most exciting areas of non-invasive treatment.

Q2. What was the core mission or the “problem you wanted to solve” when you started iSMART?

I’ve always been a huge advocate for light therapy because I’ve seen firsthand the amazing transformations it can bring. The results we saw in clinical trials with the professional-grade models were truly life-changing for some people.

But I also knew that this technology shouldn’t be limited to clinics or hospitals. I wanted to make LED therapy, or photobiomodulation, more accessible, without compromising on the clinical standards or safety that define a doctor-led treatment. LED therapy is so versatile and safe, and I wanted more people to be able to experience its healing and rejuvenating benefits in their own homes.

At that time, LED for home use was still developing. Our mission with iSMART was clear: to create scientifically proven, safe, accessible LED therapies that empower people, whether professionals or at-home users, to take control of their skin health, wellness, and confidence.

Q3. Why do you personally believe so much in light therapy as a treatment?

For me, it’s the perfect combination of being effective, non-invasive, and gentle. There’s no downtime, no pain, no harsh side effects; just real, visible results.

From a scientific point of view, when you get the wavelength, intensity, and protocol right, your cells respond beautifully. They renew, repair, and rejuvenate. But what really inspires me is seeing how it helps people, not just in how they look, but how they feel.

Too often, the first treatments people turn to can be invasive, painful, or come with unwanted side effects. LED offers a safe and effective alternative. For example, our LED glove, which has been cleared for the treatment of dermatitis, can calm inflammation and irritation and strengthen the skin barrier, all without the downsides of steroid creams. It’s helping people heal from the inside out, which is what light therapy is really about.

Q4. How do your company values reflect this belief and shape your approach to product development?

From day one, I wanted iSMART products to truly work; to make people feel better, inside and out. But that also meant ensuring they could stand up to the highest levels of scrutiny for safety and efficacy. I personally believe it’s unacceptable for health and wellness products to go to market without rigorous testing.

That’s why it was so important for us to become an ISO 13485-certified company. It keeps us accountable and ensures we’re always delivering the highest-quality, safest products possible.

Our values really drive everything we do:

• Innovation – we never stop pushing boundaries to see what’s next.
• Quality – every device reflects our commitment to excellence and safety.
• Collaboration – we love working with partners and sharing our success.
• Sustainability – we’re conscious of how we design and manufacture.
• Empowerment – we want people to feel confident and in control of their wellbeing.

And we’re still just scratching the surface of what LED can do for the human body — that’s what keeps me inspired every day.

Q6. As LED therapy becomes more well-known, what challenges does iSMART face?

Our biggest challenge is that the market still isn’t as regulated as it should be. We put an enormous amount of time and care into our research, development and regulatory compliance which is why our devices continue to perform so well globally. But not all devices are created equal, and that’s something we’re passionate about educating people on.

We want consumers, and professionals, to really understand what makes good LED therapy: things like correct wavelengths, dosing, and safety standards. Without proper design and validation, light therapy can be misunderstood or even dismissed, which is such a shame. So we’ve made education and scientific integrity a core part of who we are.

We are also committed to campaigning with the regulatory groups to make sure that there is more control of the LED marketplace with only safe and properly regulated devices being brought to market.

Q7. Looking ahead, what excites you about the future of light therapy and iSMART’s role in it?

Honestly, so much! Light therapy is no longer just about skin rejuvenation, we’re seeing it used for pain relief, inflammation, wound healing, and even in broader wellness routines. People are discovering how powerful it can be for overall health and vitality, and that’s really exciting to me.

We’re also committed to making LED therapy more accessible at home, so anyone can benefit from it, not just those who visit clinics. And as we innovate, we’re also focused on doing things sustainably; creating products that are both effective and kind to the planet.

Collaboration is another big one for us. Working with brands and experts around the world allows us to share knowledge and bring trusted, science-backed solutions to more people.

At iSMART, we want to stay at the forefront of LED technology, not just leading innovation, but helping redefine what skincare, health, and wellness can look like for everyone.

 

iSMART Developments is proud to announce that its handLITE device has received FDA clearance (K250224) as the world’s first non-UV light therapy device indicated for the treatment of irritant contact dermatitis (ICD) of the hand.

This milestone cements iSMART’s position at the forefront of LED therapy innovation, following closely behind the recent clearance of the world’s first light therapy device for the treatment of wrinkles in the décolletage area. Both achievements showcase the company’s continued commitment to pioneering safe, effective, and clinically proven solutions for unmet medical needs.

Dermatitis of the hand remains a significant challenge, affecting hundreds of millions of people globally each year. Based on published data from 2025, it is estimated that chronic cases impact approximately 376 million adults annually. Women are disproportionately affected, often due to higher exposure to common irritants in both domestic and occupational settings. Traditional treatments often involve the long-term use of topical steroids or immunomodulators, both of which are associated with side effects and patient compliance issues. Until now, there have been no FDA-cleared non-UV light therapy devices available for treating this condition.

The handLITE device harnesses the power of clinically validated red (630nm) and near-infrared (830nm) wavelengths to deliver targeted photobiomodulation therapy.

A controlled clinical crossover study demonstrated that treatment with handLITE resulted in statistically significant reductions in dermatitis severity. After the first treatment course 96% of subjects reported that their dermatitis had improved from baseline with over half of the study group indicating that their dermatitis had improved greatly, almost cleared or completely cleared, with 76% reporting improvements in pruritus. Importantly, no adverse events were reported, reinforcing the device’s strong safety profile and suitability for convenient at-home use.

Sue D’Arcy, CEO and Founder of iSMART Developments, commented: “This latest FDA clearance marks another major milestone for the team at iSMART. It underscores our commitment to developing advanced, non-invasive therapies that fill real gaps in the market.

Our handLITE device offers a highly effective alternative for patients seeking to manage their dermatitis without the risks associated with steroidal or immunosuppressive treatments. Building on the success of our décolletage wrinkle treatment clearance, we are proud to continue shaping the future of LED-based healthcare solutions through clinical research.”

The FDA clearance of handLITE for dermatitis not only opens new avenues for patients but also signals an important opportunity for pharmaceutical partners and new product development teams seeking innovative, evidence-backed therapies.

iSMART Developments continues to lead the way in advancing phototherapy beyond more traditional use, with a robust pipeline of future innovations already underway.

For more information on new product development, distribution or applying your own branding to our existing product line, please get in touch with us here.

The LED mask market is booming, but how do you separate marketing hype from genuine skin-transforming technology?

According to Sue D’Arcy, CEO of iSMART, a leading global manufacturer of LED phototherapeutic devices, the answer lies in three crucial parameters: Wavelength, Intensity, and Dose.

Get just one of these wrong, and your LED mask could be ineffective—or worse, unsafe!

Wavelength

Different wavelengths penetrate the skin at varying depths, targeting specific cells and chromophores (molecules that absorb particular wavelengths and reflect colour). Using an incorrect wavelength means missing your intended target, reducing effectiveness significantly. Clinically proven wavelengths, such as 1070nm, are essential. Notably, 1070nm is the only deeper-penetrating wavelength FDA-cleared for tissue healing, demonstrating proven biological effects on skin regeneration.*

Intensity

Intensity refers to the power delivered by the LED to targeted skin tissues. Excessively high intensity can inhibit cellular responses or even cause harm, whereas too low intensity won’t adequately stimulate the skin cells to achieve the desired therapeutic benefits. Striking the right balance is critical for achieving visible, safe, and sustainable results.

Dose

Dose is calculated as Intensity multiplied by Time (Intensity x Time). Ensuring the correct treatment duration is essential. If miscalculated, users risk overexposure, potentially leading to skin damage or underexposure, rendering the treatment ineffective.

 

Sue D’Arcy explains: “Consumers are often misled by brands claiming ‘more power equals better results.’ Without the correct balance of these three elements, an LED mask is merely an expensive gimmick.”

With over 20 years of expertise behind industry-leading LED mask developments for top brands such as Omnilux, The Light Salon, Beauty Pie, and more, iSMART is dedicated to educating both consumers and beauty professionals about scientifically validated LED phototherapy.

If you’re writing about LED masks, beauty technology, or skincare science, Sue D’Arcy is available for expert commentary, insightful interviews, and myth-busting conversations.

*DEN090012 indicated for shortening the time to healing of herpes simplex labialis lesions on or around the lips.

UK-based skincare, aesthetic and medical device innovator iSMART Developments has announced a major breakthrough with FDA 510(k) clearance of its décoLITE LED device, making it the first in the world cleared for wrinkle treatment specifically targeting the décolletage area.

This clearance is a game-changer for the aesthetic device market, as décoLITE offers a clinically proven, non-invasive solution to a concern often overlooked in traditional skincare. The device utilises red and near-infrared light to reduce wrinkles and pigmentation through a process called photobiomodulation. In a six-week clinical trial, 84% of participants reported visible improvements in skin texture, pigmentation, and wrinkle depth.

The milestone FDA clearance further establishes iSMART as a leader in light-based anti-ageing technology. With its flexible, wearable design, décoLITE is set to redefine skincare convenience and efficacy for consumers worldwide.

As the device rolls out in the US under its new OHS classification, iSMART is preparing to set a new standard in at-home skin rejuvenation.

If you’re interested in partnering with iSMART – please get in touch with us.

I was recently asked by a friend of mine what I thought of the flood of “LED beauty masks” onto the market, particularly being retailed online. So, with a cup of coffee in hand and a deep breath I typed into my search bar “Best LED mask.” Needless to say, I ended up with 167,000,000 results.

Now it would be unfair of me to call out one particular review, so instead I read over a sample of reviews that claimed they were giving the reader the “best devices currently on the market today” What I found was a series of common mis claims and common mistakes or gaffs made by these reviewers who claimed to be beauty experts. Here’s just a sample of those so-called foibles.

“you’re shining a bunch of NASA-approved lights at your face to change your entire skin tone”

The National Aeronautics and Space Administration or NASA don’t approve lights or light emitting diodes for that matter. You’ll often see this claim as if NASA has waved a magical wand over certain Light emitting diodes and certain devices over others. It’s not correct. In the early 2000’s Dr Harry Whelan authored several papers on the successful use of LED in space to heal wounds and used the word NASA LEDs. Since then hundreds of companies have labelled their devices as NASA approved or using NASA LEDs when in fact there really is no basis for their claim.

“Shines a rainbow of light to treat your common skin conditions from wrinkles to rosacea”

It seems that some of these manufacturers want to offer you a multitude of colors to treat a myriad of conditions.

Green light: has a wavelength of 495–570 nm and a quick search on Pubmed reveals no real significant clinical data to prove it works on pigmentation. Orange light: 590–620 nm, searches on Pubmed and Google scholar draw a blank.

White light: – well white light is white light, like the light that comes out of your bedside lamp and that really doesn’t do much at all apart from light up your bedroom!

So, what wavelengths or colors really work?

The research group of Michael Hamblin (Wellman Center for Photomedicine at Massachusetts General Hospital) published several research papers identifying the complex cellular mechanisms potentially explaining how light therapy works on reducing facial wrinkles, healing wounds and smoothing skin texture. In several of his papers his group made a statement that basically light from around 600nm (red) to 1000nm (near infra-red) has some effect at the cellular level. However, there’s a big caveat in play here, because it’s not only the color of the light, signified by the wavelength but other parameters such as the energy or the power of the light and how quickly the light is delivered to the skin. Think about it like baking a cake, there’s a list of ingredients – but it’s the weights and measures and how you combine them that counts. Sure we can suggest that amber light works, but until Dr Rocha Mota publishes their data on red versus amber light, I am sticking to the clinically proven wavelengths of light, Red at 633nm and near infra-red at 830nm, proven in clinical studies to improve facial wrinkles, smooth surface roughness and improve overall tone. Why look elsewhere – those 2 wavelengths have been proven in the right combination to work, the others (apart from yellow1) have not.

1. There are a handful of clinical publications on yellow light improving wrinkles and helping to heal radiation induced dermatitis.

“The best LED masks include at least 2 important wavelengths: red and blue.”

There’s a grain of truth in this, but only if you want to treat mild to moderate acne vulgaris. Red and blue light combined is more efficacious than blue light alone for treating acne vulgaris. A comparison of clinical data goes some way to prove this. However, if you really want to treat the signs of skin ageing then Red at 633nm and near infra-red at 830nm are the proven wavelengths of choice and the wavelengths recognized by regulatory bodies such as the Food and Drug administration (FDA) to be effective.

“LED masks may not kill the degree of acne-causing bacteria or stimulate collagen at the rate an in-office treatment might.”

Don’t be fooled, if a manufacturer understands the importance of how the light is delivered to the skin, then some home use masks, especially those that lie close to or on the skin can perform just as well. As I mentioned earlier, phototherapy is a combination of several key parameters; the wavelength of the light (color) the intensity of the light, the time of the treatment and how close the device is to the skin, get all 4 correct and you will see the same benefits from a home use mask as you will from an in office LED device and what’s more you can treat your skin more frequently without the need to visit the physician’s office.

“Uses FDA approved technology”

The Food and Drug administration (FDA) doesn’t approve a technology, they clear devices for marketing. It is in fact illegal to sell an LED mask indicated for the treatment of wrinkles and/or acne vulgaris in the US without an FDA clearance or K number. I looked at five devices listed in various “best LED mask” reviews. These names appeared in several “reviews” and yet none appeared to be FDA cleared for the treatment of wrinkles or acne vulgaris. Don’t believe me? Well the FDA make it easy for you – here’s the link https://www.fda.gov/medical-devices/510k-clearances/search-releasable-510k-database. You can search the releasable 510(k) database by Device name.

So, a handful of devices recommended by experts in the field and yet none have been cleared for sale in the USA by the FDA and therefore there is no particular guarantee of how safe and effective these devices are?

“the most powerful LEDs”

This is a common mistake by manufacturers claiming that they have the most powerful LEDs and that power is great and more effective -wrong. I am repeating myself once again and I apologise but effective phototherapy is a combination of several key parameters;
i. The wavelength of the light (color)
ii. The intensity of the light (how quickly the light is delivered)
iii. The time of the treatment
iv. How close the device is to the skin?

If the light is too powerful, then it can deliver too much light to the skin and the skin’s cellular mechanism cannot cope, so all of this light is wasted and actually has a negative effect. Phototherapy obeys a law called the Arndt Schulz Rule. Too little light has no effect on the cell, too much light has an inhibitory effect and in the middle is the cell’s sweet spot, where the right amount of light energy using the right wavelengths of light delivered in the right amount of time will give the best results.

“FDA Registered technology” – “FDA cleared technology”

Some companies claim they are FDA registered – that may be true, but this does not mean that the device has been cleared for marketing in the US, it just means that they have registered their company and product on the agencies website to allow import of the product. Their product has not had to undergo rigorous testing.
Some of these companies claim they are using FDA cleared technology – it’s snake oil salesman talk. They are implying that their technology is the same, but again the agency does not clear “technology” per se they clear devices that have clear trade names and give those products K numbers.
If you are ever in doubt and you reside in the US use the link above to the FDA’s own website to check out product.

LED technology is having more than just a moment, right now. This intelligent technology is completely revolutionising the beauty industry and now, it’s even being used to treat various health conditions – including those suffered by dogs.

Due to be released next year, the HEALED LED WRAP has been expertly engineered to provide pain relief for dogs, without involving costly trips to see the vet. This revolutionary concept treats pain and inflammation in animals, enabling them to enjoy a more comfortable and happy life.

Various different diseases, medical conditions and physical injuries are to blame for inflammation in pets, and whilst this issue is incredibly common, more often than not, it goes improperly treated. Pain relief tends to be the go-to ‘solution’ when it comes to inflammation, but all this does is temporarily mask the discomfort. Instead, we should be looking towards more natural ways to alleviate the pain – using proven healing remedies to treat the cause rather than the symptom.

And that’s where the HEALED LED WRAP comes in.

Completely pain-free and portable, the HEALED LED WRAP is super easy to use and has been built with the same technology used to treat thousands of humans. The wrap employs clinically proven wavelengths of red and near infrared light to effectively reduce inflammation and pain, promote tissue repair and improve mobility.

How does light therapy work?

A pioneering technology, LED light therapy directly targets the multiple factors associated with pain, stimulating the cellular processes to promote soft tissue healing and repair. HEALED LED WRAP reduces inflammatory markers, effectively calming the tissue. This direct pain relief inhibits peripheral nerve conduction.

What does light therapy do?

Light therapy is clinically proven to relieve muscle and joint pain, as well as arthritis, muscle spasms and joint stiffness. It promotes the relaxation of muscle tissue and depending on where on the body the brace is applied, temporarily increases blood circulation. All of this together helps ensure optimum pain relief for dogs.

What can the HEALED LED WRAP be used for?

The HEALED LED WRAP can be used to treat and reduce the impact of an array of diseases, conditions and physical injuries. Acute and persistent pain caused by inflammatory conditions such as arthritis are reduced, together with general aches and pains experienced by older pets and injury to cruciate ligament. This groundbreaking product also treats post operative pain, successfully accelerating wound healing for a more timely recovery.

And even more amazingly, the incredible impacts of the HEALED LED WRAP aren’t limited solely to physical ailments. A real game-changer for pet owners, this revolutionary product has been proven to reduce neuropathic pain, arthritis, injuries and even anxiety.

Dogs with a nervous temperament or those that are prone to spells of anxiety can hugely benefit from the effects of the brace. The light therapy stimulates serotonin which can significantly reduce stress and anxiety – great news for anyone with a timid or jumpy dog.

Looking good makes us feel fabulous, and so the cosmetic industry continues to thrive. Whether we are going out for a few drinks or we’re simply heading into the office on a gloomy Monday morning, a bit of makeup and a spritz of perfume makes us feel great about ourselves.

But after being hit with the Coronavirus pandemic, restrictions were implemented that triggered a major shift in the beauty industry. Not being able to go to restaurants, bars and shops removed the ‘need’ for makeup, and having the freedom to work from home gave us the chance to take a break from cosmetics. For the first time in forever, we could just let our skin breathe.

Covid-19 presented the perfect opportunity to pair things back, moving our focus away from makeup, and onto skincare. We seized the chance to step up our at-home beauty regimens, resulting in an acceleration in the market growth of beauty devices.

The pandemic majorly influenced our beauty habits, initiating key trends such as app-connected devices, multifunctional devices and in particular, anti-aging devices.

According to an in-depth study carried out by Klines, of the various different skincare categories, anti-aging was the only one to experience double digit growth, indicating just how determined we are to retain our youthful looks. So, as well as pamper parties on Zoom and DIY eyelash curling kits, for many, the pandemic is when LED face masks really captured interest.

Aesthetic treatments such as botox, thread lifts and laser therapies have become increasingly popular in recent years, but as cosmetic clinics were forced to close amid government rules, we were left with no option but to explore alternatives – and LED face masks proved incredibly popular.

What’s so amazing about LED face mask technology is that it targets an array of skin concerns, rather than one specific problem. From the first signs of ageing, fine lines and wrinkles to hyperpigmentation, acne and rosacea, an LED face mask acts as a workhorse – a real multitasker. And the popularity of this skincare technology only continues to grow.

LED technology is used by dermatologists, clinicians and at-home consumers alike, and meanwhile spas and clinics are now back open, the popularity of LED face masks continues to flourish. Indulging in a treatment performed by a professional is always enjoyable, but when you can achieve those same great results whilst sitting on your living room sofa, why wouldn’t you?!

An ever-evolving world that’s constantly seeing new brands and product releases, it can be hard to stay up-to-date with the latest goings on in the beauty industry. But one thing’s for certain, LED technology is by far the most exciting thing to happen to aesthetics in a long time.

This innovative and revolutionary technology targets a variety of skin concerns to help transform the look of our complexions. From reducing fine lines and wrinkles and erasing redness to diminishing acne and removing veins, LED skincare does just about everything – and guess what? You can achieve the results you want, right in the comfort of your own home.

The Natural Face Lift Company has paved the pathway for LED face mask technology, developing clinically-proven phototherapy devices that effectively rejuvenate the skin.

These expertly-engineered devices are trusted by professional dermatologists worldwide and now, thanks to the development of FaceLite, it’s no longer necessary to head to the clinic for treatments.

LED technology has truly transformed the beauty industry, enabling people to significantly improve skin texture and appearance, effortlessly. Unlike topical treatments, LED masks get to work immediately, from the moment they come into contact with the skin. And the results speak for themselves.

Fast-acting and with clinically-proven results, these masks are empowering both women and men alike to embrace their natural complexions. For many years, there has been a focus on clever makeup tips and tricks (contouring, baking and so on), but now, we are seeing a shift. Natural skin is ‘in’, and LED technology is empowering people that have continually hidden behind makeup to go bare-faced. They are proud of the skin they are in and no longer feel dependent on heavy foundations and full-coverage concealers to cover their imperfections.

In a world where aesthetic treatments have become as easily-accessible as a fresh set of gel nails, such an effective and non-invasive product is incredibly refreshing. Consumers can look forward to a youthful, glowing complexion without the need for surgery or injectables. This pioneering product is remoulding the beauty industry as we know it, making naturally radiant skin an attainable reality for everyone.