# K251149: AviClear Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Cutera, Inc.
- Decided: Jul 11, 2025 after 88 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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: 7 generations back to K002421 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230660: AviClear Laser System, Cutera, Inc. (2023) Summary page 5.

## Indications for use
The AviClear Laser System is indicated for the long-term treatment of mild to severe inflammatory acne vulgaris.

Source page: https://510kreport.com/device/K251149
Methodology: https://510kreport.com/methodology