Identity
- Trade Name
- Slit lamp delivery unit (SL-1800) FDA UDI
- Generic Name
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
- Device Name
- This delivery unit is connected to the GYC-1000 main body to comprise the photocoagulation system and to treat affected areas using the slit lamp, NIDEK SL-1800. A slit lamp delivery unit that includes the SL-1800 comprises a photocoagulation system in connection with the GYC-1000 main body. FDA UDI
- Model / Reference
- 17421-0000 FDA UDI
- Description
- This delivery unit is connected to the GYC-1000 main body to comprise the photocoagulation system and to treat affected areas using the slit lamp, NIDEK SL-1800. A slit lamp delivery unit that includes the SL-1800 comprises a photocoagulation system in connection with the GYC-1000 main body. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669100219 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
Slit lamp delivery unit (SL-1800) by Nidek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General/multiple surgical frequency-doubled solid-state laser system.
- GreenLight HPS — AMERICAN MEDICAL SYSTEMS, INC. · Class II
- SPECTRA — Lutronic Corporation · Class II
- Powered Laser Surgical Instrument－Nice Station Light Based Platform — Beijing Syntech Laser Co., Ltd. · Class II
- GreenLight™ Laser System Footswitch — Boston Scientific · Class II
- OcuLight TX Laser Console — Iridex Corporation · Class II
- HELIOS 785 Pico Foot Switch — Laseroptek Co., Ltd · Class II
- Lightlas SeLecTor Deux — Lightmed Corp. · Class II
- HELIOS Ⅲ 1064 Fractional Handpiece — Laseroptek Co., Ltd · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nidek, Inc.
Sources (1)
- FDA UDI b927189b-7437-4623-8278-f7ac92018402 34 fields · synced May 30, 2026