# K133358: Nidek Multicolor Laser Photocoagulator System MC-500 Connected with the Endophotocoagulation Delivery Unit

- Pathway: 510(k) (Traditional)
- Applicant: Nidek Co., Ltd.
- Decided: Aug 12, 2014 after 285 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K894841 (1989). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110228: Nidek Multicolor Laser Photocoagulator, Nidek Incorporated (2011) Summary page 5.
- K021696: 20G Sma Laser Fiber, Model LF20; 25G Sma Laser Fiber, Model LF25, Ophthalmed, LLC (2002) Summary page 5.
- K122997: 23GA Curved Illuminating Laser Probe, Peregrine Surgical, Ltd. (2013) Summary page 5.
- K032085: Green Laser Photocoagulator Model Gyc-1000, Nidek, Inc. (2003) Summary page 5.

## 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.

## Indications for use
The Endophotocoagulation Delivery Unit (for sterilized endophoto probe) is intended to be used in ophthalmic surgical procedures for retinal photocoagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.

Source page: https://510kreport.com/device/K133358
Methodology: https://510kreport.com/methodology