# K990780: Nuvolase 532 Cutaneous Laser System

- Pathway: 510(k) (Special)
- Applicant: American Laser Medical
- Decided: Mar 22, 1999 after 13 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: 1 generation back to K970667 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970667: Nuvo-Lase 660 Laser System, American Laser Medical (1997) Summary page 1.

## Indications for use
VASCULAR LESIONS: CAPILIARY HEMANGIOMA (PORT-WINE STAIN) STRAWBERRY HEMANGIOMA TELANGIECTASTA ROSACEA PIGMENTED LESIONS: FRECKLES AGE SPOTS CAFE-AU-TAIT LENTIGO

Source page: https://510kreport.com/device/K990780
Methodology: https://510kreport.com/methodology