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Green Laser Photocoagulator GYC-500
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref B01E005Model YLC-500, GYC-500, MC-500510(k) K152603
Identity
- Trade Name
- Green Laser Photocoagulator GYC-500 EUDAMEDGreen Laser Photocoagulator FDA UDI
- Generic Name
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
- Device Name
- The NIDEK Green Laser Photocoagulator GYC-500 is a laser photocoagulator for ophthalmology using a 532 nm diode-pumped solid-state laser (green laser beam) as the treatment beam source. The device incorporates a diode-pumped laser that enables efficient laser beam emission at 532 nm. For the laser beam delivery, various types of delivery units may be employed. This allows performance of transpupillary photocoagulation using a slit lamp or binocular indirect ophthalmoscope. FDA UDI
- Model / Reference
- YLC-500, GYC-500, MC-500 EUDAMEDB01E005 EUDAMEDGYC-500 FDA UDI
- Description
- The NIDEK Green Laser Photocoagulator GYC-500 is a laser photocoagulator for ophthalmology using a 532 nm diode-pumped solid-state laser (green laser beam) as the treatment beam source. The device incorporates a diode-pumped laser that enables efficient laser beam emission at 532 nm. For the laser beam delivery, various types of delivery units may be employed. This allows performance of transpupillary photocoagulation using a slit lamp or binocular indirect ophthalmoscope. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669100851 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 EUDAMEDClass 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
Green Laser Photocoagulator GYC-500 by Nidek Co., Ltd. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152603 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 4987669220G6 | Class IIb | Active |
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Manufacturer
- Manufacturer
- NIDEK.CO.Ltd.,
- EUDAMED SRN
- JP-MF-000040151
- FDA Applicant
- Nidek Co., Ltd.
- Authorised Representative
- NIDEK SA FR-AR-000000341
Sources (3)
- EUDAMED 61484f7d-5ebd-4272-95e4-609557fbc712 85 fields · synced Jun 18, 2026
- FDA UDI 0a6d4289-f781-4737-bfd1-3780d7458dae 34 fields · synced May 30, 2026
- FDA 510(k) K152603 1 fields · synced May 18, 2026