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Multicolor Laser Photocoagulator MC-500

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref B01E003Model YLC-500, GYC-500, MC-500Ref B02E002

by NIDEK.CO.Ltd.,

Identity

Trade Name
Multicolor Laser Photocoagulator MC-500 EUDAMED
Yellow Laser Photocoagulator FDA UDI
Multicolor Laser Photocoagulator FDA UDI
Generic Name
General/multiple surgical frequency-doubled solid-state laser system FDA UDI
Device Name
The NIDEK YELLOW LASER PHOTOCOAGULATOR YLC-500 is an ophthalmic laser photocoagulator consisting of a main laser device, a control box, and a power supply. With various types of laser delivery units, it comprises a photocoagulation system. The YLC-500 uses a 577 nm optically pumped semiconductor laser (yellow laser beam) as the treatment beam source. The pumped yellow laser beam (treatment beam) and the aiming beam (635 nm, red laser beam) are fed coaxially into the fiber optic cable. The output terminal of the fiber optic cable is connected to a delivery unit. The laser beam is formed into the desired spot size by the optical system, then the laser beam is emitted to the target area. The delivery units are equipped with a protective filter that protects the physician’s eyes from exposure to the treatment beam reflected from the patient’s eye or contact lens. FDA UDI
The NIDEK Multicolor Laser Photocoagulator MC-500 is a laser photocoagulator for ophthalmology with the light source of wavelengths 647, 577, and 532 nm. As the conventional laser photocoagulators, the MC-500 can be used for retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity, and retinal detachment, or for laser iridotomy and laser trabeculoplasty for treatment of glaucoma. The device incorporates two types of lasers (diode-pumped solid state laser and laser diode) which enable efficient obtainment of laser beam oscillation of each wavelength. As the conventional device, various types of laser delivery units can be used. Therefore, transpupillary photocoagulation can be performed using various delivery units such as slit lamps and binocular indirect ophthalmoscope. FDA UDI
Model / Reference
YLC-500, GYC-500, MC-500 EUDAMED
B01E003 EUDAMED
B02E002 EUDAMED
YLC-500 FDA UDI
MC-500 FDA UDI
Description
The NIDEK YELLOW LASER PHOTOCOAGULATOR YLC-500 is an ophthalmic laser photocoagulator consisting of a main laser device, a control box, and a power supply. With various types of laser delivery units, it comprises a photocoagulation system. The YLC-500 uses a 577 nm optically pumped semiconductor laser (yellow laser beam) as the treatment beam source. The pumped yellow laser beam (treatment beam) and the aiming beam (635 nm, red laser beam) are fed coaxially into the fiber optic cable. The output terminal of the fiber optic cable is connected to a delivery unit. The laser beam is formed into the desired spot size by the optical system, then the laser beam is emitted to the target area. The delivery units are equipped with a protective filter that protects the physician’s eyes from exposure to the treatment beam reflected from the patient’s eye or contact lens. FDA UDI
The NIDEK Multicolor Laser Photocoagulator MC-500 is a laser photocoagulator for ophthalmology with the light source of wavelengths 647, 577, and 532 nm. As the conventional laser photocoagulators, the MC-500 can be used for retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity, and retinal detachment, or for laser iridotomy and laser trabeculoplasty for treatment of glaucoma. The device incorporates two types of lasers (diode-pumped solid state laser and laser diode) which enable efficient obtainment of laser beam oscillation of each wavelength. As the conventional device, various types of laser delivery units can be used. Therefore, transpupillary photocoagulation can be performed using various delivery units such as slit lamps and binocular indirect ophthalmoscope. FDA UDI

Identifiers

Primary DI / UDI-DI
04987669101117 EUDAMEDFDA UDI
04987669100080 EUDAMEDFDA UDI
Basic UDI-DI
4987669220G6 EUDAMED
FDA Product Code
HQF FDA UDI
EMDN Code
Z12120202 LASER PHOTOCOAGULATORS EUDAMED
GMDN Term
General/multiple surgical frequency-doubled solid-state laser system FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
886.4390 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Multicolor Laser Photocoagulator MC-500 by Nidek Co., Ltd. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
NIDEK.CO.Ltd.,
EUDAMED SRN
JP-MF-000040151
Authorised Representative
NIDEK SA FR-AR-000000341

Sources (4)

  • EUDAMED 49a7c11a-5e6c-4650-863a-9e3ee548cf53 61 fields · synced Jul 29, 2026
  • FDA UDI 63d63cc8-6074-451a-8ed2-937a056b2b9f 34 fields · synced May 30, 2026
  • FDA UDI 2ff51677-de3c-448a-b7ec-d8ceccde40a3 34 fields · synced May 30, 2026
  • EUDAMED f688bd1d-bb86-4eb8-8e01-417be953a2db 61 fields · synced Jul 29, 2026