# K213726: PL-1 Skin Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: AVAVA, Inc.
- Decided: Jun 28, 2022 after 214 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: 27 generations back to K943450 (1995). 299 ancestors in all.
No later device cites it as a predicate yet.
0 of 300 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202503: Chrome, Quanta System Spa (2020) Summary page 4.

## Indications for use
The PL-1 Skin Treatment System is a 1064 nm laser system intended to ablate, vaporize, and coagulate soft body tissues for aesthetic and cosmetic applications in the medical specialties of dermatology and plastic surgery. It is also indicated for removal of benign pigmented lesions including; nevus of Ota, café au lait spot, ephelides, solar lentigo (lentigines), Becker's nevus, nevus spilus and treatment of common nevi.. The PL-1 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.

Source page: https://510kreport.com/device/K213726
Methodology: https://510kreport.com/methodology