Identity
- Trade Name
- Attachable delivery unit (30SL) FDA UDI
- Generic Name
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
- Device Name
- This delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 main body, to comprise the photocoagulation system and to treat affected areas using the slit lamp, Carl Zeiss Meditec 30 SL/M. This delivery unit is mainly comprised of the delivery unit, protective filter unit, and the split illumination mirror unit. This photocoagulation system allows the operator to select among photocoagulation with the red (647 nm), yellow (577 nm), or green (532 nm) laser beam and observation of the affected area with the slit lamp. This delivery unit can be attached only to the Carl Zeiss Meditec 30 SL/M. FDA UDI
- Model / Reference
- 17461-0000 FDA UDI
- Description
- This delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 main body, to comprise the photocoagulation system and to treat affected areas using the slit lamp, Carl Zeiss Meditec 30 SL/M. This delivery unit is mainly comprised of the delivery unit, protective filter unit, and the split illumination mirror unit. This photocoagulation system allows the operator to select among photocoagulation with the red (647 nm), yellow (577 nm), or green (532 nm) laser beam and observation of the affected area with the slit lamp. This delivery unit can be attached only to the Carl Zeiss Meditec 30 SL/M. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669100127 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
Attachable delivery unit (30SL) 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 a1ea6c79-b796-4c96-a190-4d2a0a4c6f26 34 fields · synced Jun 1, 2026