Next-Gen AVAVA Platform Cleared by FDA for Wrinkle Reduction Across All Skin Types

AVAVA, a next-generation, nonablative energy platform powered by proprietary Focal Point Technology, has received US FDA clearance for the treatment of fine lines and wrinkles across Fitzpatrick skin types I to VI.¹ 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 multisite clinical trial involving 33 participants who underwent facial wrinkle treatment with the AVAVA system. Clinical evaluation demonstrated statistically significant wrinkle reduction (P < .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 postinflammatory 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.²

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.

Expert Perspectives on AVAVA’s Impact

With this new clearance, several expert clinicians commented on the efficacy of AVAVA’s technology and how it has impacted their practice.¹

• “As an early adopter of AVAVA, I’ve seen firsthand how its precision-based energy delivery is changing the way we approach wrinkle treatment. The technology provides measurable improvement across all skin types while maintaining comfort and consistency—hallmarks of how we practice at PFRANKMD.”—Paul Jarrod Frank, MD, a cosmetic dermatologist at PFRANKMD in New York, New York.
• “AVAVA represents a true leap forward in precision-based wrinkle treatment. Its ability to target multiple skin depths with unparalleled accuracy allows me to deliver meaningful, natural-looking results across all skin tones."—Marie V. Hayag, MD, FAAD, board-certified dermatologist and assistant clinical professor at Mount Sinai Hospital in New York, New York.
• “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.”—Jody Comstock, MD, cosmetic dermatologist at Skin Spectrum in Tucson, Arizona.

Market Growth and Company Vision

The aesthetic device market in the United States is valued at more than $8 billion, and AVAVA continues to expand, delivering results that create patient loyalty and practice growth.

“Our vision has always been to go beyond what’s expected,” Irina Erenburg, PhD, AVAVA president and CEO, said in a statement. “AVAVA stands for precision, control, and confidence, empowering providers and patients alike to achieve results that feel natural, not manufactured.”¹

References

1. AVAVA earns new FDA clearance for the treatment of wrinkles. News release. AVAVA. October 23, 2025. Accessed October 24, 2025. https://www.globenewswire.com/news-release/2025/10/23/3172520/0/en/AVAVA-Earns-New-FDA-Clearance-for-the-Treatment-of-Wrinkles.html

2. Manstein D, Chan HH, Bhawalkar J, et al. Focal point technology: controlling treatment depth and pattern of skin injury by a novel highly focused laser. J Am Acad Dermatol. 2025;92(1):78-84. doi:10.1016/j.jaad.2024.09.004