Oculight SL/SLx
FDA 510(k)Class II (US FDA 510(k))
by Iridex Corp
Identifiers
- 510(k) Number
- K020374 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 Oculight SL/SLx is an ophthalmic laser system designed for clinical use. It is indicated for procedures including retinal photocoagulation, laser trabeculoplasty, and transscleral cyclophotocoagulation.
This device utilizes a solid-state electronic switching power supply and a dedicated microprocessor to monitor system functions. It is regulated under FDA 510(k) clearance and meets EN60601-1 performance and safety standards.
Frequently asked questions
What clinical procedures is the Oculight SL/SLx indicated for?
This ophthalmic laser system is indicated for use in retinal photocoagulation, laser trabeculoplasty, and transscleral cyclophotocoagulation procedures.
How does the Oculight SL/SLx monitor its internal functions?
The device utilizes a dedicated microprocessor to monitor system functions, ensuring consistent performance during clinical use.
What safety standards does this laser system meet?
The Oculight SL/SLx is designed to meet EN60601-1 performance and safety standards for medical electrical equipment.
What is the regulatory status of the Oculight SL/SLx?
The device is regulated under FDA 510(k) clearance, which indicates it has been found substantially equivalent to legally marketed predicate devices.
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 OcuLight SL/SLx Laser Systems - IRIDEX, PDF IRIDEX OcuLight SL/SLx Operator Manual, Iridex IRIS Medical OcuLight SL Operator's Manual, Iridex IRIS Medical OcuLight SL Operator's Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K020374 | Class II | Active |
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Manufacturer
- Manufacturer
- Iridex Corp
Sources (1)
- FDA 510(k) K020374 24 fields · synced Sep 26, 2026