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Cutera Develops the First and Only FDA-Cleared Device to Revolutionize the Treatment of Acne

Article-Cutera Develops the First and Only FDA-Cleared Device to Revolutionize the Treatment of Acne

Sponsored by Cutera Acne is a leading concern for patients of all ages, as it can leave visible scarring and negatively affect self-confidence and self-esteem. Until now, the leading acne treatments were systemic, often accompanied by side effects that impeded some patients from obtaining treatment, and led to aesthetic physicians passing acne patients to their dermatologist peers. But that is about to change.

Sponsored by Cutera

Acne is a leading concern for patients of all ages, as it can leave visible scarring and negatively affect self-confidence and self-esteem. Until now, the leading acne treatments were systemic, often accompanied by side effects that impeded some patients from obtaining treatment, and led to aesthetic physicians passing acne patients to their dermatologist peers. But that is about to change.

Cutera Develops the First and Only FDA-Cleared Device to Revolutionize the Treatment of AcneAviClearTM by Cutera (Brisbane, Calif.), reportedly the first and only FDA-cleared device that can treat mild, moderate and severe acne vulgaris, is a non-toxic and non-chemical solution that comes with no safety warnings. Aesthetic physicians and dermatologists can now treat acne on all skin types with a safe and effective device with no risk of harmful side effects. AviClear will soon be the preferred choice to clear acne, especially for patients who have not experienced successful clearance on systemic therapy or are seeking a drug-free yet effective solution.

AviClear Key Features

Michael Karavitis, PhD, executive vice president and chief technology officer for Cutera, explained that issues with current acne treatments, such as needing a prescription and lack of long-term results, led to the development of AviClear. “Acne is the number one condition presented in dermatology and one of the main reasons that people start seeing a dermatologist. Not only is acne a heartbreaking condition, but it can affect the trajectory of people’s lives,” he shared. “Developing a solution and technology like AviClear felt like the right thing to do. I am proud to say we have a solid, first-to-market device with AviClear.”

Most acne treatments do not target the production of sebum,1 yet AviClear addresses acne at its source using specific wavelengths to target and suppress the sebaceous glands. Dr. Karavitis explained the key features that differentiate AviClear from other acne treatments. “There are three standout features. The first is the 1726 nm wavelength, which is a unique wavelength that has been traditionally hard to generate. The 100-Watt power is the second key feature. Generating a 1726 nm wavelength along with that amount of power can be difficult, but we were able to Cutera Develops the First and Only FDA-Cleared Device to Revolutionize the Treatment of Acnesuccessfully engineer a device that does just that. Lastly, the AviCoolTM sapphire cooling feature cools on contact, making the treatment tolerable for most patients.”

Cutera is dedicated to defining and progressing the medical aesthetics industry through innovation of advanced technology as well as support that places physicians and their practices at the forefront of the market. According to Dave Mowry, chief executive officer of Cutera, “Acne has significant clinical needs, and acne patients are the largest demographic to visit the dermatologist. Over the last three decades, there have been no modern solutions, and a general lack of innovation in acne treatment. We saw this as a huge market opportunity, but we also looked at the patient experience and understood how rewarding it would be to be able to help relieve people from the stigma associated with acne.”

Developing AviClear was an endeavor that kept patients and modern lifestyles top of mind, with demands for an easy-to-follow treatment and satisfactory results at the forefront. “We have a much better safety profile than other treatments. We are using a natural energy source of light that is focused to deliver the right therapeutic dosage to the right part of the body,” Mr. Mowry explained. “An issue with the popular acne treatment, isotretinoin (trade name: Accutane), is that it is contraindicated with alcohol, so it may not be a choice for young people who are engaging in their social exploration. AviClear is a modern alternative that can meet the lifestyle and needs of the population versus a synthetic drug.”

Clinical Trials

With extensive clinical trials and strong clinical data, AviClear received FDA clearance in March 2022. Ashish Bhatia, MD, associate professor of clinical dermatology at Northwestern University and co-founder of Oak Dermatology (Itasca, Joliet and Naperville, Ill.), often provides clinical input on Cutera’s emerging technologies, and is one of the first to own AviClear and use it in his practice. “The clinical trials were performed as a monotherapy treatment which is particularly encouraging when you see long-term results out to two years,” he explained. “We have noticed in both the pilot and pivotal studies that the results of AviClear continue to improve over time, with some patients showing long-term clearance over two years after their final treatment. Patients of any skin type can be treated safely with good results, and they found the treatment comfortable as no patient dropped out of the study due to pain. This offers hope for patients who have not had success with other treatments, whether it be oral antibiotics, topicals, lasers or isotretinoin.”

Emmy Graber, MD, MBA, founder of The Dermatology Institute of Boston (Boston, Mass.), specializes in acne and cosmetic dermatology. She told us the clinical data of AviClear was especially significant for patients with moderate and severe acne. “I was really impressed with the improvement of nodules in patients with severe acne,” she exclaimed. “Usually, we see some improvement with nodules, but we really think of using isotretinoin for these. I was very impressed and surprised to see a 69% improvement of nodules after treatment with AviClear, which is huge. There are very few options for patients that have a lot of nodules and severe acne, so I was excited to see AviClear was effective in this regard.”

Along with being an encouraging treatment for severe acne, Dr. Graber also noted the wide range of patients that will benefit from AviClear. “What further impressed me about the study, was not only did it include patients with both moderate and severe acne, but it also included patients of all Fitzpatrick skin types,” she said. “There are many patients with skin of color and darker skin types who did very well with the treatment. There were no reported cases of hyperpigmentation in all of the 104 patients.”

But there is more behind this impressive number. Mr. Mowry explained that the most interesting and important data point from the entire study was not just the patient enrollment but the patient follow-up. “We had 104 of the 107 patients complete the study,” he emphasized. “And that is, in my mind, an endorsement from the patients that they not only wanted the treatment, but they enjoyed it, and were satisfied with the results.”

According to Mr. Mowry, the overall results mimic those of the current gold standard therapy for the clearance of acne – especially moderate and severe acne.

Early checkpoints showed data similar to that of isotretinoin; and moreover, the final results were not significantly different than those that have been published for isotretinoin. Reaching the gold standard of data without the challenges of systemic drugs will ultimately define Cutera’s success with AviClear.

Cutera Develops the First and Only FDA-Cleared Device to Revolutionize the Treatment of AcneIn terms of numbers, clinical studies indicated that 80% of study patients saw at least half of their acne clear after the recommended treatment protocol of three 30-minute sessions. At week twelve 87% of the patients reported being “satisfied” or “very satisfied”. This success came with no significant adverse events while all post-treatment effects were transient and self-resolving.”2

Patient Compliance and the Benefits of AviClear

Until now, traditional acne treatments required patient compliance and commitment, making it difficult to see long-term results, especially for teenage and young adult patients. But another hurdle facing physicians is that patients and their families prefer natural treatments to medications, when possible. “Many are leery about taking oral antibiotics, especially for long periods of time,” explained Jeffrey Dover, MD, dermatologist and director of SkinCare Physicians (Chestnut Hill, Mass.), “Isotretinoin is difficult to prescribe and has at least two significant side effects and many irritating, less significant, side effects. Only one month of isotretinoin may be prescribed at a time, so patients have to come into the office many times during their six-month course of treatment, which adds a significant burden onto the patient and their families.”

Dr. Bhatia has found similar hurdles in treating acne patients. “While isotretinoin works well, it comes with significant side effects and warnings; it also requires the iPledge program. Some parents and patients are hesitant to go this route,” he said. “Another hurdle we have when treating acne is compliance. The majority of acne sufferers are young adults with busy, active lifestyles, making it a challenge to maintain consistency in their treatments. AviClear requires only three, 30-minute in-office treatments, which is great for patients since it easily fits into their active lifestyles.”

In addition to addressing these patient issues, the AviClear features an easy-to-use interface, enabling treatments to be delegated to a physician extender (dependent on state laser licensure laws), which can improve patient throughput as well as ROI for the practice.

“To me, the key feature is the ease of use,” stated Tahl Humes, DO, founder and medical director at Vitahl Medical Aesthetics (Denver, Colo.). “A lot of what we do for our patients can be labor intensive for us, or it may be a treatment that takes a long time. AviClear is a speedy treatment that is easy and comfortable for a clinician to do.” Furthermore, with AviClear, patients do not have to change their lifestyle, making this treatment protocol easy to follow with continued improvements as a result.

Traditional acne treatments not only come with compliance issues, but they may also be uncomfortable due to side effects. Dr. Graber reported that the safety features of AviClear can help physicians clear this hurdle. “The AviCool contact cooling allows for safety of the epidermis so that you do not see any of the hyperpigmentation that can plague other devices,” she explained. “The contact cooling also makes it tolerable for patients without the need for topical anesthesia, which really speaks volumes to the design of this device. I was also impressed with the light system on the handpiece that indicates if there is sufficient contact with the skin, and that it is safe to deploy the laser pulse.”

Cutera Develops the First and Only FDA-Cleared Device to Revolutionize the Treatment of AcneThe AviClear Advantage

AviClear can expand patient reach and satisfaction because it does not require a prescription and can be used to treat all skin types. In addition, it is compatible to use with other therapies. Dr. Graber plans to use the device in combination with other treatments. “I will have some patients taking an antibiotic pill or a combined oral contraceptive that may be getting results, but their acne is not totally clear,” she began. “If that is the case, we can use the AviClear laser in addition to the oral treatment and treat the remaining acne by selectively targeting the sebaceous glands.”2

Dr. Bhatia shared that he will use AviClear as a monotherapy treatment, especially for patients who may not be candidates for, or who have failed, other therapies. However, he has already devised a method to bring out the versatility of this treatment and boost patient outcomes by using it in combination with other procedures.

Cutera’s history of innovation has provided forward-thinking aesthetic physicians and practitioners with solutions for achieving superior outcomes in face and body rejuvenation. Dr. Humes has recognized this opportunity to use AviClear in combination with other revolutionary procedures. “With AviClear, we saw that the integrity of the texture of their skin got better, and we can improve on it even more with Laser Genesis (Cutera). I think what we will see is that we will be doing these combo treatments on the same day.”

Changing the Future of Aesthetics with AviClear

“The potential for the new AviClear device for treating acne is significant,” Dr. Dover exclaimed. “This is the first and only FDA-cleared device which appears to significantly improve the treatment of moderate to severe acne on and off the face. This may be one of the biggest developments in the treatment of acne since the introduction of Accutane in the early 1980s.”

Having such an impact on how acne is treated makes it inevitable that it will impact aesthetic practices. According to Mr. Mowry, AviClear will be a cash-based procedure, with the economics closely modeling the out-of-pocket expenses that patients face with a prescription treatment. “Even though isotretinoin may be covered by insurance, the co-payments for the lab, the co-payments for the prescription and the co-payments for the physician visits add up over seven or eight times, so I think the economics are about even. I believe that we win on safety, efficacy and convenience without giving anything away on economics,” he shared.

Being a dermatologist, Dr. Graber treats a wide range of acne patients. “AviClear really puts acne patients in the hands of cosmetic practices and patients can now be treated by the aesthetic provider because the AviClear laser is so effective. This really broadens the scope of aesthetic practices, and everyone can benefit from AviClear; practices can benefit from having it and patients can benefit from its efficacy.”

Avi360 Partnership

With the introduction of AviClear, Cutera is also introducing a full partnership approach with practitioners and physicians that is focused on customer support and driven by their new Concierge team. As part of Avi360, physicians will have a one-stop shop, where the Concierge team will coordinate installation, training and onboarding while providing them with support throughout the partnership. Another area of Avi360 is the marketing efforts with the Key Account Management team that will provide local support as well as national marketing efforts to help drive awareness of the AviClear brand.


Cutera has opened the door for aesthetic physicians and practitioners to expand their patient portfolio and increase their revenue by providing a solution to treat acne patients instead of referring them to prescription-based treatment. And with a delegable procedure and 30-minute treatment times, AviClear has become a versatile and profitable procedure that will enhance aesthetic practices everywhere.

As Dr. Dover points out, devices are rarely used to treat acne – until now. “The early data using the new Cutera device shows the potential for a durable response with more patients improving six months after their last treatment compared to three months after the last treatment despite receiving no other therapy. AviClear will allow aesthetic physicians and practitioners to provide a durable, drug-free, non-systemic solution to treating acne, and that is a game changer.”3

1. Chovatiya R. Acne treatment. JAMA. 2021;326(20):2087
2. Data on file, FDA clearance study. Cutera, Inc
3. Treatments can be delegated to a qualified healthcare provider as determined by state laser licensure laws

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