AVAVA Receives FDA Clearance for Wrinkle Treatment Using Focal Point Technology
Key Insights
AVAVA (search) announced FDA clearance for treating fine lines (search) and wrinkles (search) across all skin tones (Fitzpatrick I-VI) using its non-ablative energy platform.
Clinical studies demonstrated statistically significant wrinkle improvement (p < 0.001) with an average 1.7-point improvement on the dermatologist-graded Wrinkle and Elastosis Scale.
Patient satisfaction surveys showed 100% would recommend the treatment, with 97% describing the experience as enjoyable and 85% returning to normal activities immediately.
AVAVA (search) announced FDA clearance for treating fine lines (search) and wrinkles (search) across all skin tones, marking another regulatory milestone for the company's non-ablative energy platform. The clearance, announced October 23, 2025, follows the company's recent FDA approval for acne scar treatment and expands the device's indications to include wrinkle treatment for Fitzpatrick skin types I-VI.
Clinical Evidence Supports Efficacy
In a multi-site study of 33 subjects submitted to the FDA, AVAVA (search) demonstrated statistically significant wrinkle improvement (p < 0.001). Most participants showed visible wrinkle reduction with an average 1.7-point improvement on the dermatologist-graded Wrinkle and Elastosis Scale.
"As an early adopter of AVAVA (search), I've seen firsthand how its precision-based energy delivery is changing the way we approach wrinkle treatment," said Paul Jarrod Frank, M.D., Cosmetic Dermatologist in New York City. "The technology provides measurable improvement across all skin types while maintaining comfort and consistency."
High Patient Satisfaction Rates
A separate single-site survey captured real-world patient experience across 125 patients and 284 treatments. The results showed exceptional satisfaction rates:
- 100% said they would have another treatment and recommend AVAVA
- 97% described their experience as enjoyable
- 85% returned to normal activities immediately
"AVAVA (search) represents a true leap forward in precision-based wrinkle treatment," said Marie V. Hayag, M.D., FAAD, Board-Certified Dermatologist. "Its ability to target multiple skin depths with unparalleled accuracy allows me to deliver meaningful, natural-looking results across all skin tones."
Focal Point Technology Drives Results
The device's core technology, Focal Point Technology, directs energy into precise, predictable depths within the skin. The company describes this as the "Martini Effect," a conical beam design that focuses energy deep in the skin to renew collagen and elastin (search) without the excess disruption seen in older laser systems.
"The ability to achieve measurable texture and tightening improvement across all skin types with minimal downtime truly sets it apart. The patient satisfaction is remarkable," said Jody Comstock, M.D., Board-Certified Dermatologist.
The platform integrates ComfortCool cooling technology and the AVAVASync digital ecosystem to enhance both provider experience and treatment outcomes.
Market Positioning
AVAVA (search) positions itself for expansion in the $8-billion U.S. aesthetic device market. The company, formed from Blossom Innovations (search) and led by the inventors of Fraxel, aims to deliver consistent results with enhanced control for providers.
"Our vision has always been to go beyond what's expected," said Irina Erenburg, Ph.D., President & CEO. "AVAVA (search) stands for precision, control, and confidence, empowering providers and patients alike to achieve results that feel natural, not manufactured."