FDA Clears Cutera’s AviClear™ Acne Device
AviClear is the First Device Cleared for the Treatment of Mild, Moderate and Severe Acne
AviClear has been Proven Safe and Effective Through an Extensive Clinical Trial
Provides Long-term Resolution of Acne Across All Skin Types
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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,” said
"Physicians and patients have long sought a modern alternative to the acne pills, peels and topicals that have been static for nearly 30 years,” said
AviClear is expected to be made available to physicians throughout
Data on file, FDA clearance study.
- O’Neill AM, Gallo RL. Host-microbiome interactions and recent progress into understanding the biology of acne vulgaris. Microbiome 2018;6: 177.
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