Identifiers
- 510(k) Number
- K010372 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 Lightlas 532 Photocoagulator is an ophthalmic laser device used for retinal photocoagulation. It is a solid-state laser system operating at 532 nm wavelength with a power output of 2.0W, designed for treating various retinal diseases.
The device is supplied as a console unit and includes slit lamp delivery adapters for integration with Haag-Streit style slit lamps. It is intended for use in ophthalmic clinical settings and has received FDA 510(k) clearance under product code HQF and regulation number 886.4390.
Frequently asked questions
What is the Lightlas 532 Photocoagulator used for?
The Lightlas 532 Photocoagulator is used for retinal photocoagulation in ophthalmic clinical settings to treat various retinal diseases, utilizing a 532 nm wavelength solid-state laser system with a power output of 2.0W.
How is the Lightlas 532 Photocoagulator supplied and integrated into clinical use?
The device is supplied as a console unit and includes slit lamp delivery adapters designed for integration with Haag-Streit style slit lamps, enabling use in standard ophthalmic examination setups.
What regulatory pathway was used for the Lightlas 532 Photocoagulator?
The Lightlas 532 Photocoagulator received FDA 510(k) clearance under product code HQF and regulation number 886.4390, with a traditional clearance pathway and a substantially equivalent decision based on the submitted 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: LIGHTLas 532 Green Photocoagulation - lightmed.com, PDF 532-web-2025 - LIGHTMED, LIGHTLas 532 - Salientmed, Retinal photocoagulation laser - LIGHTLas 532 Integrated System ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K010372 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lightmed Corp.
Sources (1)
- FDA 510(k) K010372 24 fields · synced Sep 24, 2026