# K131894: Nidek Green Laser Photocoagultor Model Gyc-1000 Connected with the Endophotocoagulation Delivery Unit

- Pathway: 510(k) (Special)
- Applicant: Nidek Co., Ltd.
- Decided: Oct 31, 2013 after 128 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: 4 generations back to K894841 (1989). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032085: Green Laser Photocoagulator Model Gyc-1000, Nidek, Inc. (2003) Summary page 2.

## Indications for use
The Nidek Green Laser Photocoagulator Model GYC-1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

Source page: https://510kreport.com/device/K131894
Methodology: https://510kreport.com/methodology