# K250402: AVAVA™ Skin Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: AVAVA, Inc.
- Decided: Apr 14, 2025 after 61 days
- Product code: ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 24 generations back to K910422 (1992). 330 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 332 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223871: Miria Skin Treatment System, AVAVA, Inc. (2023) Summary page 5.

## Most influential descendants
- K252155: AVAVA™ Skin Treatment System (2025), 0 descendants of its own

## Indications for use
The AVAVA™ Skin Treatment System is indicated for use in the treatment of acne scars, and dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. The AVAVA™ Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions. The AVAVA™ Skin Treatment System is a prescription device. Federal law restricts this device to sale by or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.

Source page: https://510kreport.com/device/K250402
Methodology: https://510kreport.com/methodology