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LightLas 561 Ophthalmic Photocoagulator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K063297

by Lightmed Corp.

Identifiers

510(k) Number
K063297 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 561 Ophthalmic Photocoagulator is a Class II laser device designed for ophthalmic photocoagulation procedures. It emits laser energy at a 561 nm wavelength to treat ocular tissues, including the retina and trabecular meshwork, as part of therapeutic interventions for retinal diseases or glaucoma management.

This device is intended for use in clinical ophthalmology settings and is supplied as a reusable medical system comprising a laser console, delivery system, and control interface. It has received FDA 510(k) clearance under the Traditional pathway, with no third-party review. The device is not classified as MRI-safe or sterile upon packaging and must be handled according to manufacturer guidelines for maintenance and reprocessing.

Frequently asked questions

What types of ocular conditions is the LightLas 561 Ophthalmic Photocoagulator primarily used to treat in clinical practice?

The LightLas 561 is designed for ophthalmic photocoagulation procedures targeting the retina and trabecular meshwork. Clinically, it is used to manage retinal diseases—such as diabetic retinopathy or retinal tears—and glaucoma by delivering precise laser energy to specific ocular tissues as part of therapeutic interventions.

Is the LightLas 561 Ophthalmic Photocoagulator supplied as a single-use device or intended for reuse in clinical settings?

The device is supplied as a reusable medical system, consisting of a laser console, delivery system, and control interface. It requires proper maintenance and reprocessing according to the manufacturer’s guidelines, as it is not sterile upon packaging.

How was the regulatory pathway for the LightLas 561 Ophthalmic Photocoagulator determined, and what does that mean for its use?

The device was cleared via the FDA’s Traditional 510(k) pathway, determined to be *substantially equivalent* to a predicate device. This means it underwent a review comparing its technical characteristics to an existing approved laser system, ensuring safety and effectiveness for ophthalmic photocoagulation without third-party committee involvement.

Does the LightLas 561 Ophthalmic Photocoagulator come with any built-in safety features for MRI environments, or is it safe to use near MRI machines?

The device is explicitly *not* classified as MRI-safe. Clinicians must ensure it is removed from the MRI environment or stored appropriately to avoid interference, as laser systems like this are not designed for use in magnetic resonance imaging settings.

What should clinicians consider when storing or handling the LightLas 561 before and after use?

Since the device is reusable and not sterile, clinicians must follow manufacturer guidelines for reprocessing, maintenance, and storage to ensure proper functionality and infection control. It should be stored in a clean, dry environment away from direct sunlight or extreme temperatures, and any accessories or consumables should be handled according to sterile protocols if used in procedures.

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 561 OPTHALMIC PHOTOCOAGULATOR - Innolitics, LIGHTMED, LIGHTMED | Medical Laser Technologies | Photocoagulation

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Lightmed Corp.

Sources (1)

  • FDA 510(k) K063297 24 fields · synced Sep 19, 2026