# K951079: Nidek Model Gyc-1500 and Gyc-2000

- Pathway: 510(k) (Traditional)
- Applicant: Nidek, Inc.
- Decided: Sep 14, 1995 after 189 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
No predicates in its family tree.
19 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K980547: Nidek Prima Model Gyc-1500/2000 (1998), 18 descendants of its own
- K032085: Green Laser Photocoagulator Model Gyc-1000 (2003), 17 descendants of its own
- 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

Source page: https://510kreport.com/device/K951079
Methodology: https://510kreport.com/methodology