AVAVA Earns New FDA Clearance for the Treatment of Wrinkles
The High-Energy Non-Ablative Platform Redefining What’s Possible in Skin Revitalization
WALTHAM, Mass., Oct. 23, 2025 (GLOBE NEWSWIRE) -- AVAVA, the powerful non-ablative energy platform powered by Focal Point Technology™, today announced FDA clearance for the treatment of wrinkles, marking another milestone in its mission to reshape the future of aesthetics.
This latest clearance, coming just months after FDA approval for acne scars, is for fine lines and wrinkles in the Fitzpatrick I-VI. It reinforces AVAVA’s leadership in next generation energy-based devices that deliver visible, natural-looking results across all skin tones, with minimal disruption and little to no downtime.
“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, M.D., Cosmetic Dermatologist in New York City. “The technology provides measurable improvement across all skin types while maintaining comfort and consistency, hallmarks of how we practice at PFRANKMD.”
Clinically Proven. Patient-Loved.
In a multi-site study of 33 subjects for facial treatment submitted to the FDA, AVAVA® demonstrated statistically significant wrinkle improvement (p < 0.001), with most participants showing visible wrinkle reduction with an average 1.7-point improvement on the dermatologist-graded Wrinkle and Elastosis Scale.
In a separate single site, in-clinic survey intended to capture real world patient experience, AVAVA polled 125 patients across 284 treatments. All reported exceptional satisfaction with their treatment experience.*
- 100% said they would have another treatment and recommend AVAVA®
- 97% described their experience as enjoyable
- 85% returned to normal activities immediately
“AVAVA® 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.”
The Difference: Redefining Precision and Performance
At the core of AVAVA® is Focal Point Technology™, a breakthrough technology that directs energy into precise, predictable depths within the skin. Known as the “Martini Effect™”, this conical beam design focuses energy deep in the skin to renew collagen and elastin, 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.
Paired with ComfortCool™ integrated cooling and the AVAVASync™ digital ecosystem, AVAVA® bridges science, artistry, and intelligence, transforming both the provider experience and the business of aesthetics.
Results Patients Love. Technology Investors Trust.
By combining measurable clinical outcomes with exceptional satisfaction, AVAVA is poised for continued expansion in the $8-billion-and-growing U.S. aesthetic device market. Providers cite its ability to deliver consistent results with unmatched control, driving patient loyalty and practice growth.
“Our vision has always been to go beyond what’s expected,” said Irina Erenburg, Ph.D., President & CEO. “AVAVA stands for precision, control, and confidence, empowering providers and patients alike to achieve results that feel natural, not manufactured.”
About AVAVA
AVAVA is redefining what’s possible in energy-based aesthetics. Combining Focal Point Technology™, ComfortCool™ integrated cooling, and the AVAVASync™ digital ecosystem, AVAVA® delivers precision skin revitalization for all tones and all generations. Formed out of Blossom Innovations and led by the inventors of Fraxel®, AVAVA continues to pioneer the next era of aesthetic technology through fearless vision and boundless energy.
Media Contact:
Stacy Mackler
Public Relations, AVAVA
smackler@avavaskin.com
*Data from AVAVA Clinic on file at AVAVA, Inc
Photos accompanying this announcement are available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/9b989d67-8304-49e3-b07b-9d431e13b490
https://www.globenewswire.com/NewsRoom/AttachmentNg/71196b9e-22fb-419c-ab28-6d09bfc57377
https://www.globenewswire.com/NewsRoom/AttachmentNg/9474bdef-53a3-4b23-8cdb-355093e2c2ce
https://www.globenewswire.com/NewsRoom/AttachmentNg/79add6b3-8fe0-4cfd-bd81-0d7da4ad891e
Wrinkle B&A - 4 Months Post 3 Tx
Photos Courtesy of AVAVA Research Clinic
Wrinkle B&A - 3 Months Post 3 Tx
Photos Courtesy of Dr. Thanh-Nga Tran
Wrinkle B&A - 5 Months Post 3 Tx
Photos Courtesy of Dr. Thanh-Nga Tran
Wrinkle B&A - 5 Months Post 2 Tx
Photos Courtesy of AVAVA Research Clinic
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