# K990725: Nuvolase 532 Laser System

- Pathway: 510(k) (Special)
- Applicant: American Laser Corp.
- Decided: Mar 22, 1999 after 17 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 K972561 (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)
- K972561: Nuvolase 660 Laser System for Ophthalmology, American Laser Medical (1997) Summary page 1.

## Indications for use
RETINAL AND MACULAR PHOTOCOAGULATION TRABECULOPLASTY

Source page: https://510kreport.com/device/K990725
Methodology: https://510kreport.com/methodology