# K974732: Nidek Multi Color Laser Photocoagulator, Model MC-7000

- Pathway: 510(k) (Traditional)
- Applicant: Nidek, Inc.
- Decided: Mar 18, 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: 1 generation back to K930543 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932468: Novus Multiwavelength, Coherent Medical Group (1993) Summary page 1.
- K930543: E-25 Krypton Ion Laser (Surgica K5), Hgm, Inc. (1993) Summary page 1.

## Indications for use
Delivery of Laser therapeutic radiation is accomplished by two basic means: Transpupillary: 1) Via an optical system attached to a viewing microscope either a slit-lamp or operating microscope. Retinal therapy is further aided by the use of an auxiliary viewing lenses, typically a fundus laser lens, or a wide field examination lens with a laser anti-reflection coating. Anterior segment therapy is further aided by viewing lenses which can reflect the treatment beam into the chamber angle, either with or without magnification. The lens is treated on the distal surface with a laser anti-reflection coating. 2) Via an optical system attached to an indirect ophthalmoscope either binocular or monocular, with or without auxiliary viewing lenses. Typically a +20 Diopter examination lens with a laser anti-reflection coating is employed. Inter Operative methods: 1) Via direct radiation administered from a fiber optic cable handpiece which is inserted through an incision and positioned proximal to a point of treatment within the eye. According to the area to be treated, the fiber handpiece be formed in either a straight or curved manner. Transpupillary laser therapy is commonly employed for the following indications: Retinal Photocoagulation, either limited or Pan-Retinal Macular Photocoagulation Trabeculoplasty for Open Angle Glaucoma Iridotomy for Acute Angle Closure Glaucoma Inter-Operative laser therapy is employed for the following indications: Retinal Photocoagulation, either limited or Pan-Retinal Macular Photocoagulation

Source page: https://510kreport.com/device/K974732
Methodology: https://510kreport.com/methodology