Identity
- Trade Name
- Bio delivery unit (OMEGA 500) FDA UDI
- Generic Name
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
- Device Name
- The delivery unit is connected to the Yellow Laser Photocoagulator YLC-500 to comprise the photocoagulation system and to treat affected areas using a binocular indirect ophthalmoscope. The photocoagulation system enables photocoagulation using a yellow laser beam (577 nm) while observing the patient’s eye with the binocular indirect ophthalmoscope. FDA UDI
- Model / Reference
- GDD01 FDA UDI
- Description
- The delivery unit is connected to the Yellow Laser Photocoagulator YLC-500 to comprise the photocoagulation system and to treat affected areas using a binocular indirect ophthalmoscope. The photocoagulation system enables photocoagulation using a yellow laser beam (577 nm) while observing the patient’s eye with the binocular indirect ophthalmoscope. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669101162 FDA UDI
- FDA Product Code
- HQF FDA UDI
- GMDN Term
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4390 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: General/multiple surgical frequency-doubled solid-state laser system
Bio delivery unit (OMEGA 500) by Nidek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nidek, Inc.
Sources (1)
- FDA UDI e5a86e9b-7e42-4def-947d-78b81cd5bf99 34 fields · synced May 30, 2026