# K042785: Multi Color Laser Photocoagulator, Model MC-300

- Pathway: 510(k) (Traditional)
- Applicant: Nidek, Inc.
- Decided: Dec 14, 2004 after 69 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: 4 generations back to K894841 (1989). 17 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 33 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 2.
- K022181: Novus Varia Ophthalmic Laser and Delivery Devices with Accessories, Lumenis, Inc. (2002) Summary page 2.

## Most influential descendants
- 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
- K103547: Lightlas Multi-Wavelength Medical Laser System (2011), 2 descendants of its own
- K201623: LION Photocoagulator (2020), 1 descendant of its own

## Indications for use
The Nidek Multi Color Laser Photocoagulator Model MC-300 is indicated to be used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

Source page: https://510kreport.com/device/K042785
Methodology: https://510kreport.com/methodology