Nidek Multicolor Laser Photocoagulator System MC-500 with Endophotocoagulation Delivery Unit
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K133358 FDA 510(k)
- FDA Product Code
- HQF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4390 FDA 510(k)
- Regulation Number
- 886.4390 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Nidek Multicolor Laser Photocoagulator System MC-500 is a Class II ophthalmic laser device designed for retinal photocoagulation procedures. It delivers precise laser treatments, including panretinal photocoagulation for diabetic retinopathy and laser iridotomy for glaucoma, using multicolor laser technology. The system is equipped with a slit lamp delivery unit for targeted retinal applications, enabling controlled tissue modification under direct visualization.
The MC-500 is supplied as a connected system, combining the main photocoagulator unit with an endophotocoagulation delivery unit for clinical use. It is intended for single-use or reusable components as specified by the manufacturer, with regulatory authorizations including FDA 510(k) clearance and MDR compliance. The device operates in sterile or controlled clinical environments, adhering to regulatory standards for ophthalmic laser systems under the classification HQF. Storage and handling follow manufacturer guidelines to maintain performance and safety.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MC-500/500 Vixi ― Multicolor Laser Photocoagulator | NIDEK USA, Multicolor Scan Laser Photocoagulator MC-500 Vixi Multicolor Laser ..., Nidek Multicolor Laser Photocoagulator System Mc-500 Connected With the ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K133358 | Class II | Active |
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Manufacturer
- Manufacturer
- Nidek Co., Ltd.
Sources (2)
- FDA 510(k) K133358 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 19, 2026