# K152603: Green Laser Photocoagulator GYC-500

- Pathway: 510(k) (Traditional)
- Applicant: Nidek Co., Ltd.
- Decided: May 2, 2016 after 234 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K894841 (1989). 20 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 27 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 5.
- K110228: Nidek Multicolor Laser Photocoagulator, Nidek Incorporated (2011) Summary page 5.
- K111493: Nidek Multicolor Scan Laser Photocoagulator MC-500 Vixi, Nidek Co., Ltd. (2011) Summary page 5.

## Most influential descendants
- K190083: Leaf Photocoagulator (2019), 3 descendants of its own
- K201623: LION Photocoagulator (2020), 1 descendant of its own
- K170302: Yellow Laser Photocoagulator Ylc-500 (2017), 1 descendant of its own
- K251507: Integre Lio (2026), 0 descendants of its own
- K251772: Navilas Laser System 577sl (156691) (2025), 0 descendants of its own

## Indications for use
The Green Laser Photocoagulator GYC-500 is intended to be used in ophthalmic surgical procedures including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

Source page: https://510kreport.com/device/K152603
Methodology: https://510kreport.com/methodology