Identity
- Trade Name
- BIO delivery unit (Heine OMEGA) FDA UDI
- Generic Name
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
- Device Name
- The Binocular Indirect Ophthalmoscope (hereafter called BIO) delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 (main body), to comprise the photocoagulation system and applied to the treatment of the affected area using the BIO delivery unit (HEINE OMEGA 500). The comprised photocoagulation system allows the operator to select between thermal photocoagulation with the multicolor laser beam (treatment beam) (wavelength: green (532 nm), yellow (577 nm), and red (647nm)) and observation with the BIO. FDA UDI
- Model / Reference
- 17379-0000 FDA UDI
- Description
- The Binocular Indirect Ophthalmoscope (hereafter called BIO) delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 (main body), to comprise the photocoagulation system and applied to the treatment of the affected area using the BIO delivery unit (HEINE OMEGA 500). The comprised photocoagulation system allows the operator to select between thermal photocoagulation with the multicolor laser beam (treatment beam) (wavelength: green (532 nm), yellow (577 nm), and red (647nm)) and observation with the BIO. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669100110 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 (Heine OMEGA) 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 e61f8433-b2d5-4273-9a4d-710b085c3e2a 34 fields · synced May 30, 2026