# K202884: SR-1 Skin Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: AVAVA, Inc.
- Decided: Apr 13, 2021 after 197 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: 21 generations back to K910422 (1992). 327 ancestors in all.
4 later devices descend 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)
- K130193: Fraxel Dual 1550/1927 Laser System, Solta Medical, Inc. (2013) Summary page 4.
- K060310: Fraxel II SR Laser System and Accessories, Reliant Technologies, Inc. (2006) Summary page 4.
- K193500: Stellar M22 for Intense Pulsed Light (IPL) and Laser System, Lumenis, Ltd. (2020) Summary page 4.
- K130028: Resurfx 1565NM Laser Module, Lumenis, Ltd. (2013) Summary page 4.

## Most influential descendants
- K221268: SR-1 Skin Treatment System (2022), 3 descendants of its own
- K223871: Miria Skin Treatment System (2023), 2 descendants of its own
- K250402: AVAVA™ Skin Treatment System (2025), 1 descendant of its own
- K252155: AVAVA™ Skin Treatment System (2025), 0 descendants of its own

## Indications for use
The SR-1 Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. The SR-I 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 SR-1 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/K202884
Methodology: https://510kreport.com/methodology