# K110228: Nidek Multicolor Laser Photocoagulator

- Pathway: 510(k) (Special)
- Applicant: Nidek Incorporated
- Decided: Feb 23, 2011 after 28 days
- Product code: HQB (Photocoagulator And Accessories)
- Device class: 2
- Regulation: 21 CFR 886.4690
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K894841 (1989). 18 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042785: Multi Color Laser Photocoagulator, Model MC-300, Nidek, Inc. (2004) Summary page 1.

## Most influential descendants
- K152603: Green Laser Photocoagulator GYC-500 (2016), 6 descendants of its own
- 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

## Recalls of this device
- Jun 9, 2014 · Class II · Z-2132-2014: Laser aperture label was not affixed to device prior to shipment in the US.
- May 24, 2013 · Class II · Z-0222-2015: Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.
- Oct 24, 2012 · Class II · Z-0224-2015: When the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery unit occasionally fails to emit the laser, or the power output is lower than the set program.
- Mar 27, 2012 · Class II · Z-1127-2015: The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.

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

Source page: https://510kreport.com/device/K110228
Methodology: https://510kreport.com/methodology