AVAVA Receives FDA Clearance for Acne Scar Treatment on All Skin Types Using Focal Point Technology
The U.S. Food and Drug Administration (FDA) has cleared AVAVA’s Focal Point Technology™ for the treatment of acne scars, marking a significant milestone in energy-based skin therapy. The technology, developed by Boston-based AVAVA, is now indicated for acne scarring in all Fitzpatrick skin types (I–VI), addressing a critical gap in treatment accessibility and safety for patients with skin of color.
Acne scarring affects nearly half of all acne sufferers, with post-inflammatory hyperpigmentation especially common in Black and Hispanic populations.1-2 AVAVA’s platform delivers high-energy, targeted treatments without ablating the surrounding tissue—a key factor in its safe use across diverse skin tones. The system incorporates ComfortCool™ technology to reduce discomfort, with most patients reporting mild, short-lived side effects.
“This milestone reflects the strength of our clinical data,” said Richard Bankowski, Executive Vice President of Global Clinical & Regulatory at AVAVA. “We’re delivering results that matter to today’s aesthetic patients, especially those historically underserved.”
The FDA clearance follows a prospective, IRB-approved, multi-center clinical trial involving 47 participants, 75% of whom identified as African American, Asian, or Hispanic/Latino. Subjects ranged from 21 to 72 years of age, with women comprising 59% of the cohort. Independent dermatologists evaluating the results reported that more than 90% of participants showed visible improvement, including a median 50% reduction in scar severity based on the ECCA scale. Notably, some achieved complete scar clearance—even after a single treatment session.
Multiple patients were treated at, or above 120mJ, with some reaching high energy levels of 150mJ. Which is only possible with AVAVA’s proprietary Focal Point TechnologyTM. The treatment was associated with low pain scores and minimal downtime. Mild redness and swelling were observed post-treatment and resolved within 1-2 days.
“We saw consistent improvement in acne scarring across all patients,” said Roy Geronemus, MD. “The results, including patients with skin of color, are impressive. AVAVA’s technology is a true step forward in laser dermatology.”
AVAVA will present 14 abstracts and podium presentations at the upcoming ASLMS 2025 Conference, where further applications of the technology will be discussed.
1. Tan J. Prevalence and risk factors of acne scarring among patients consulting dermatologists in the USA - jddonline - journal of drugs in dermatology. JDDonline. February 2017. Accessed April 24, 2025. https://jddonline.com/articles/prevalence-and-risk-factors-of-acne-scarring-among-patients-consulting-dermatologists-in-the-usa-S1545961617P0097X.
2. Jennings T, McLarney M, Renzi M, et al. Acne scarring-pathophysiology, diagnosis, prevention and education – Part 1. Journal of the American Academy of Dermatology. Published online July 2022. doi:https://doi.org/10.1016/j.jaad.2022.04.021