Identity
- Trade Name
- Attachable delivery unit (SL130) FDA UDI
- Generic Name
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
- Device Name
- The attachable delivery unit is attached to the Carl Zeiss Meditec SL 130 (hereafter called Zeiss SL 130) to comprise a slit lamp delivery unit. The comprised slit lamp delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 to comprise a photocoagulation system. The 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. The attachable delivery unit is mainly comprised of a photocoagulation unit, a protective filter unit, and a split mirror illumination unit. FDA UDI
- Model / Reference
- 17464-0000 FDA UDI
- Description
- The attachable delivery unit is attached to the Carl Zeiss Meditec SL 130 (hereafter called Zeiss SL 130) to comprise a slit lamp delivery unit. The comprised slit lamp delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 to comprise a photocoagulation system. The 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. The attachable delivery unit is mainly comprised of a photocoagulation unit, a protective filter unit, and a split mirror illumination unit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669100141 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 (SL130) 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 c8e3d0c3-d362-4a85-8b4a-32d54cd97abe 34 fields · synced Jun 8, 2026