# K972561: Nuvolase 660 Laser System for Ophthalmology

- Pathway: 510(k) (Traditional)
- Applicant: American Laser Medical
- Decided: Oct 6, 1997 after 89 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Prima 532: named in the summary without a submission number
- (no number) Oculight GL: named in the summary without a submission number

## Most influential descendants
- K990725: Nuvolase 532 Laser System (1999), 0 descendants of its own

## Indications for use
1. Retinal and Macular photocoagulation 2. Trabeculoplasty

Source page: https://510kreport.com/device/K972561
Methodology: https://510kreport.com/methodology