Identity
- Trade Name
- Attachable 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 NIDEK Multicolor Laser Photocoagulator, Model MC-500 main body to comprise the photocoagulation system and to treat affected areas using the slit lamp, NIDEK SL-1800/SL-1600. A slit lamp delivery unit that includes the SL-1800 comprises a photocoagulation system in connection with the MC-500 main body. A attachable delivery unit is mainly comprised of a photocoagulation unit and a protective filter unit. They are attached to the NIDEK SL-1800/SL-1600 slit lamp for lasers to comprise a slit lamp delivery unit. The comprised slit lamp delivery unit is connected to the MC-500 to comprise a photocoagulation system. A 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. FDA UDI
- Model / Reference
- 17462-0000 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, NIDEK SL-1800/SL-1600. A slit lamp delivery unit that includes the SL-1800 comprises a photocoagulation system in connection with the MC-500 main body. A attachable delivery unit is mainly comprised of a photocoagulation unit and a protective filter unit. They are attached to the NIDEK SL-1800/SL-1600 slit lamp for lasers to comprise a slit lamp delivery unit. The comprised slit lamp delivery unit is connected to the MC-500 to comprise a photocoagulation system. A 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669100134 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 (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 70c817fa-3f66-4e7b-8bc3-b3e31e2df6ae 34 fields · synced May 30, 2026