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 (for ZEISS SL130) (hereafter called “attachable delivery unit”) is attached to the Carl Zeiss Meditec SL130 (hereafter called Zeiss SL130) to comprise a slit lamp delivery unit. The comprised scan slit lamp delivery unit is connected to the GYC-1000 to comprise a photocoagulation system. The attachable delivery unit is mainly comprised of a photocoagulation unit and a protective filter unit. FDA UDI
- Model / Reference
- 17404-0000 FDA UDI
- Description
- The Attachable Delivery Unit (for ZEISS SL130) (hereafter called “attachable delivery unit”) is attached to the Carl Zeiss Meditec SL130 (hereafter called Zeiss SL130) to comprise a slit lamp delivery unit. The comprised scan slit lamp delivery unit is connected to the GYC-1000 to comprise a photocoagulation system. The attachable delivery unit is mainly comprised of a photocoagulation unit and a protective filter unit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669100240 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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 ea22012a-fce2-47be-a374-2b94b7c7a45a 34 fields · synced Jun 8, 2026