AVAVA Receives FDA Clearance for Wrinkle Reduction

As reported on by Dermatology Times, AVAVA, a next-generation, non-ablative energy platform powered by proprietary Focal Point Technology, has received US Food and Drug Administration (FDA) clearance for the treatment of fine lines and wrinkles across Fitzpatrick skin types I to VI. This new indication marks a significant expansion of the device’s clinical utility, following its recent FDA clearance for the treatment of acne scars.

Clinical Efficacy and Patient Satisfaction

The FDA clearance was supported by a multi-site clinical trial involving 33 participants who underwent facial wrinkle treatment with the AVAVA system. Clinical evaluation demonstrated statistically significant wrinkle reduction (p < 0.001), with an average 1.7-point improvement on the dermatologist-graded Wrinkle and Elastosis Scale. Visible and measurable improvements were observed consistently across participants, confirming the device’s reproducibility and treatment efficacy.

Complementing these findings, an in-clinic patient experience survey was conducted among 125 patients across 284 treatment sessions. Results revealed exceptionally high satisfaction: 100% of patients indicated willingness to undergo another treatment and recommend AVAVA to others, 97% described their treatment experience as enjoyable, and 85% reported immediate return to normal daily activities.

The Technology Behind the “Martini Effect”

At the core of AVAVA’s performance is its patented Focal Point Technology, a system that delivers energy in a conical beam pattern—a design referred to as the “Martini Effect.” This innovation allows for focused energy delivery into precise, predictable skin depths, stimulating collagen and elastin renewal while minimizing surface disruption commonly associated with older laser systems. This improves skin texture and tone with a superior safety profile, particularly for patients with darker skin types who are often at higher risk of post-inflammatory pigment alteration with traditional modalities. The technology was recently highlighted in a peer-reviewed study published in the Journal of the American Academy of Dermatology.

AVAVA also integrates ComfortCool technology for real-time epidermal cooling and incorporates the AVAVASync digital ecosystem, which offers advanced treatment control, data integration, and user-friendly workflow optimization. Together, these systems provide dermatologists with enhanced procedural control while still maintaining patient comfort and satisfaction.