# K980547: Nidek Prima Model Gyc-1500/2000

- Pathway: 510(k) (Traditional)
- Applicant: Nidek, Inc.
- Decided: May 13, 1998 after 90 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: 2 generations back to K894841 (1989). 7 ancestors in all.
18 later devices descend from it; 1 cites 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)
- K962592: Ophthalas 532 Solid State Photocoagulator, or Equivalent Laser Systems, Alcon Laboratories (1996) Summary page 1.
- K962948: Ceralas G ND;Yag Laser System (Ceralas G), Ceram Optec, Inc. (1996) Summary page 1.
- K960971: Oculight GL, Iriderm Div. (1996) Summary page 1.
- K951079: Nidek Model Gyc-1500 and Gyc-2000, Nidek, Inc. (1995) Summary page 1.

## Most influential descendants
- 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
- K190083: Leaf Photocoagulator (2019), 3 descendants of its own

## Indications for use
The Nidek Prima Frequency doubled Nd:YAG Laser is intended to be used in all clinical applications for which an Argon Laser would be used in ophthalmic surgery, including Retinal and Macular Photocoagulation; Tridotomy and Trabeculoplasty.

Source page: https://510kreport.com/device/K980547
Methodology: https://510kreport.com/methodology