AviClear is the First and Original Device Cleared for the Treatment of Mild, Moderate and Severe Acne – Currently not available in Europe.
As a proud innovator and first-to-market brand, Cutera is delighted to announce AviClear received FDA 510k clearance on March 24, 2022, following our successful product development process and extensive clinical evaluation focused on a device-based treatment for acne suffers.
AviClear is a laser treatment that offers a safe, prescription-free solution for acne.1 In addition to reducing existing acne, clinical trials show that future breakout episodes are shorter, less intense, and more infrequent following the AviClear procedure. Further, acne clearance results continue to improve over time, demonstrating the long-term efficacy of this novel treatment. Importantly, no pain mitigation was utilized or required by any clinical study participant.
Acne vulgaris is a nearly universal skin disease, with approximately 50 million North American teens and young adults seeking treatment each year.2 Overproduction of sebum by the sebaceous glands is one of the leading causes of acne.3 AviClear resolves acne at the source by selectively targeting the sebocytes and suppressing sebum production.
Designed with physician and patient needs in mind, AviClear significantly reduces the severity and frequency of acne following three brief sessions without any adjunctive pain therapy. AviClear rapidly delivers laser energy in combination with AviCool™, a unique handpiece feature that provides unmatched contact cooling capability, delivering a more comfortable treatment experience.
References: 1. Data on file. Cutera Inc. 2. Data on file. FDA clearance study. Cutera Inc.3. American Academy of Dermatology/Milliman. Burden of Skin Disease. 2017. www.aad.org/BSD.
AviClear is rolling out to physicians throughout the United States over the course of 2022. Doctors and patients from Europe and outside of North America are encouraged to join the exclusive wait list and sign up for updates on product availability and local treatment providers.