# K032085: Green Laser Photocoagulator Model Gyc-1000

- Pathway: 510(k) (Traditional)
- Applicant: Nidek, Inc.
- Decided: Oct 3, 2003 after 88 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K894841 (1989). 8 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980547: Nidek Prima Model Gyc-1500/2000, Nidek, Inc. (1998) Summary page 2.

## Most influential descendants
- K042785: Multi Color Laser Photocoagulator, Model MC-300 (2004), 15 descendants of its own
- K110228: Nidek Multicolor Laser Photocoagulator (2011), 9 descendants of its own
- K152603: Green Laser Photocoagulator GYC-500 (2016), 6 descendants of its own
- K190083: Leaf Photocoagulator (2019), 3 descendants of its own
- K103547: Lightlas Multi-Wavelength Medical Laser System (2011), 2 descendants of its own

## Recalls of this device
- Mar 25, 2015 · Class II · Z-2068-2015: Accessories to the GYC-1000 laser were missing Laser Aperture labels.
- Mar 25, 2015 · Class II · Z-2067-2015: Accessories to the GYC-1000 laser were missing Laser Aperture labels.
- May 16, 2014 · Class II · Z-2120-2014: Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation,

## 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/K032085
Methodology: https://510kreport.com/methodology