# K172198: 585

- Pathway: 510(k) (Traditional)
- Applicant: Quanta System Spa
- Decided: Oct 17, 2017 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: 3 generations back to K883541 (1988). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133297: Quadrostarprogreen, Quadrostarproyellow, Asclepion Laser Technologies GmbH (2014) Summary page 4.
- K013940: Laser System Yellowstar, Asclepion-Meditec AG (2002) Summary page 4.

## Indications for use
The device is intended for treatment of benign vascular and benign pigmented lesions.

Source page: https://510kreport.com/device/K172198
Methodology: https://510kreport.com/methodology