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EU NEWSLETTER / JULY – SEPTEMBER 2022

FDA Clears Cutera’s AviClear™ Acne Device

AviClear is the First Device Cleared for the Treatment of Mild, Moderate and Severe Acne –  Not available in Europe.

Non-toxic, non-chemical, non-systemic

Safe for all skin types

High patient satisfaction

As a proud innovator and first-to-market brand, Cutera are 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.

"Existing device treatments for acne are neither long-lasting nor particularly effective...Topical therapies yield temporary results and oral medications present several challenges. AviClear offers patients a safe, well-tolerated, drug-free approach with durable results, which significantly shifts the treatment paradigm for acne"

Jeffrey S. Dover, MD, FRCPC, board-certified dermatologist and Cutera advisory board member
Before After
Before After

"Physicians and patients have long sought a modern alternative to the acne pills, peels and topicals that have been static for nearly 30 years... Developed with extensive physician and patient input, AviClear was created to redefine the treatment of acne – all without a prescription.”

David Mowry, CEO of Cutera

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.

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 visit www.AviClear.com to sign up for updates on product availability and local treatment providers.

References
1. White paper on cooling capacity of various laser skin treatment options, Data on file.

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