| K-number | K252155 |
| Device name | AVAVA Skin Treatment System |
| Applicant | AVAVA, Inc. |
| Product code | ONG |
| Device class | Class II |
| Decision date | Oct 20, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
The AVAVA Skin Treatment System is a 1550nm non-ablative fractional laser device used to treat fine lines and wrinkles, acne scars, and perform dermatologic procedures requiring soft tissue coagulation and skin resurfacing. It consists of a console, tablet interface, and patient handpiece with contact cooling, and is intended for use by trained medical professionals.
The device is identical to the predicate device in technical parameters and intended use. It features an intradermally focused laser creating a targeted spatially selective conical lesion, distinguishing it from cylindrical column-based systems. The beam can be focused to different depths for treatment of all skin tones and safety across an extended energy range.
Not stated in this summary.
The AVAVA has the same intended use, technological characteristics, and principle of operation as the predicate device (K250402). Clinical data from a retrospective trial of 28 subjects demonstrated statistically significant improvement in wrinkle scores (p < 0.001) with 75% of subjects showing at least 1-point improvement on the Fitzpatrick Wrinkle and Elastosis Scale across Fitzpatrick Skin Types I-VI, with no unanticipated adverse events, establishing safety and effectiveness for the new indication of fine lines and wrinkles treatment.
View the full FDA submission: accessdata.fda.gov