# K213461: AviClear Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Cutera, Inc.
- Decided: Mar 24, 2022 after 148 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: 5 generations back to K002421 (2000). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041242: Candela Smoothbeam Laser System, Candela Corp. (2004) Summary page 4.

## Most influential descendants
- K230660: AviClear Laser System (2023), 1 descendant of its own
- K251149: AviClear Laser System (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K213461
Methodology: https://510kreport.com/methodology