FDA Clears AVAVA Device for Wrinkle Treatment Across All Skin Types

AVAVA® has received US Food and Drug Administration (FDA) clearance for the treatment of fine lines and wrinkles across Fitzpatrick skin types I-VI, marking its second clearance in recent months following its prior approval for acne scars.

The nonablative platform, powered by Focal Point Technology™, is designed to deliver precise energy at targeted skin depths while minimizing surface disruption and downtime. In a multicenter study submitted to the FDA, treatment with AVAVA demonstrated statistically significant improvement in wrinkles (P<.001), with an average 1.7-point decrease on the dermatologist-assessed Wrinkle and Elastosis Scale across 33 subjects.

A separate single-site, in-clinic survey of 125 patients undergoing 284 treatments found that all participants would recommend the device and seek repeat treatments, with 85% resuming normal activities immediately after the procedure.

“As an early adopter of AVAVA, I’ve seen firsthand how its precision-based energy delivery is changing the way we approach wrinkle treatment,” said Paul Jarrod Frank, MD, a cosmetic dermatologist in New York City.

The AVAVA system features ComfortCool™ integrated cooling and the AVAVASync™ digital interface. Its “Martini Effect™” design allows for energy delivery in a conical pattern that promotes collagen and elastin remodeling without the collateral tissue damage associated with traditional lasers.

The device’s expanding clinical portfolio and high satisfaction scores suggest increasing traction in the aesthetic energy-based device market, currently valued at $8 billion in the US.