Supra Twin Ophthalmic Laser Photocoagulator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K081946 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 Supra Twin Ophthalmic Laser Photocoagulator is a Class II medical device designed for retinal photocoagulation procedures. It delivers laser energy at a wavelength of 532 nm to treat retinal conditions, including proliferative diabetic retinopathy and retinal detachments, through controlled application of laser spots to the retina. This device is configured as a twin-laser system, enabling simultaneous or sequential treatment with precision targeting.
This device is intended for use in ophthalmic settings with an indirect ophthalmoscope, where it is operated by trained professionals. Supplied as a reusable medical instrument, it requires proper maintenance and calibration to ensure safety and efficacy. The device holds FDA 510(k) clearance under Special Review (K081946) and adheres to regulatory standards for ophthalmic laser systems, including MRI safety considerations as outlined in regulation number 886.4390. Storage and handling must comply with manufacturer guidelines to preserve functionality and sterility.
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: PDF Quantel Medical M~~ZU Special 510(k) - Food and Drug Administration, Quantel Supra - Global DSR, SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR (K081946) — FDA 510(k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K081946 | Class II | Active |
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Manufacturer
- Manufacturer
- Quantel Medical
Sources (1)
- FDA 510(k) K081946 24 fields · synced Sep 19, 2026