The U.S. Food and Drug Administration (FDA) has cleared Avava’s acne scar laser, which is powered by Focal Point Technology.

The non-ablative laser uses Focal Point Technology to deliver energy with high accuracy, targeting the epidermis to the deep dermis. This platform is now cleared to treat acne scarring effectively with high energies in all Fitzpatrick skin types (I–VI).

Clinical Trial Shows Improvement

The FDA clearance is based on a prospective, IRB-approved, multi-center clinical trial. A total of 47 subjects were treated and evaluated by expert blinded dermatologists. Participants ranged in age from 21 to 72, with a gender split of 59% women and 41% men. Importantly, 75% of participants identified as African American, Asian, or Hispanic/Latino.

More than 90% of subjects experienced visible improvement in acne scarring with a median of 50% reduction in acne scar severity, and multiple patients in the study achieved complete scar clearance, the study showed. Fully 87% of subjects were treated at or above 120mJ, with some reaching 150mJ due to AVAVA’s proprietary Focal Point Technology. Even subjects who received only one treatment showed improvement. Side effects included mild redness and swelling and resolved within 1-2 days. With ComfortCool technology integrated into the handpiece, patients reported an average pain score of 3 out of 10, the study showed.

“We saw consistent improvement in acne scarring across all patients,” says Roy Geronemus, MD, a Dermatologist in New York, NY, in a news release. “The results, including patients with skin of color, are impressive. AVAVA’s technology is a true step forward in laser dermatology.”