Viridis Twin Ophthalmic Photocoagulator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K023464 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Viridis Twin Ophthalmic Photocoagulator is a laser surgical instrument classified under regulation number 886.4390. It is a substantially equivalent device cleared through the FDA 510(k) process under product code GEX.
The device is supplied by Quantel Medical and was cleared via traditional 510(k) submission K023464, received on October 15, 2002, and granted clearance on January 13, 2003. It is intended for use in general and plastic surgery settings as indicated by the advisory committee classification.
Frequently asked questions
What is the Viridis Twin Ophthalmic Photocoagulator used for?
The Viridis Twin Ophthalmic Photocoagulator is a laser surgical instrument intended for use in general and plastic surgery settings, as indicated by its advisory committee classification under SU (General, Plastic Surgery).
How is the Viridis Twin Ophthalmic Photocoagulator supplied and cleared for use?
The device is supplied by Quantel Medical and was cleared through the FDA 510(k) process under submission K023464, received on October 15, 2002, and granted clearance on January 13, 2003, as a substantially equivalent device under product code GEX.
What regulatory pathway was used for the Viridis Twin Ophthalmic Photocoagulator?
The Viridis Twin Ophthalmic Photocoagulator was cleared via a traditional 510(k) submission (K023464) to the FDA, demonstrating substantial equivalence to a legally marketed predicate device under product code GEX.
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: VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR (K023464) — FDA 510 (k ..., 532nm Laser Ophthalmic Service Manual | PDF | Laser | Power Supply - Scribd, Viridis Twin User Manual Rev July 2004 - BioClinical Services, VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR 510(k) K023464 - fda.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K023464 | Class II | Active |
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Manufacturer
- Manufacturer
- Quantel Medical
Sources (1)
- FDA 510(k) K023464 24 fields · synced Sep 22, 2026