Argon/Krypton Ion Laser Photocoagula
FDA 510(k)Class II (US FDA 510(k))
by Nidek, Inc.
Identifiers
- 510(k) Number
- K834305 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 Argon/Krypton Ion Laser Photocoagula is a laser device designed for ophthalmic use, specifically for retinal photocoagulation procedures. It emits coherent light from argon and krypton gas ions to create controlled tissue coagulation, primarily used in treating retinal diseases such as diabetic retinopathy and glaucoma-related conditions. This device operates by delivering precise laser energy to targeted retinal areas, promoting healing or reducing abnormal blood vessel growth.
This device is supplied as a reusable medical instrument and is classified under FDA regulation 886.4390 as a Class II ophthalmic laser. It requires proper handling, calibration, and maintenance in sterile or controlled clinical environments. The device holds an FDA 510(k) clearance (K834305) under the Traditional 510(k) review pathway, with a decision date of March 16, 1984, and is intended for use in accredited ophthalmic settings. No MRI safety information or single-use specifications are provided in the regulatory data.
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: ARGON/KRYPTON ION LASER PHOTOCOAGULA 510(k) K834305 - FDA.report, PDF K834305 - Argon/Krypton Ion Laser Photocoagula, MC-500/500 Vixi ― Multicolor Laser Photocoagulator | NIDEK USA, Green Scan Laser Photocoagulator GYC-500 Vixi, Green Laser ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K834305 | Class II | Active |
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Manufacturer
- Manufacturer
- Nidek, Inc.
Sources (1)
- FDA 510(k) K834305 24 fields · synced Sep 20, 2026