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Helios III

FDA 510(k)

Class II (US FDA 510(k))

510(k) K152856

by Laseroptek Co., Ltd

Identifiers

510(k) Number
K152856 FDA 510(k)
FDA Product Code
GEX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Helios III is a Q-Switched Nd:YAG laser system designed to provide a uniform beam profile and stable output energy. It utilizes a laser resonator designed to compensate for thermally induced lens and birefringence to maintain consistent beam quality during operation.

This device is supplied with a range of handpieces to facilitate various treatment conditions. It has received FDA 510k clearance under the product code GEX.

Frequently asked questions

What is the primary function of the Helios III laser system?

The Helios III is a Q-Switched Nd:YAG laser system engineered to deliver a uniform beam profile and stable output energy. It utilizes a specific laser resonator design that compensates for thermally induced lens and birefringence to ensure consistent beam quality throughout clinical operation.

How is the Helios III system configured for different clinical needs?

The device is supplied with a range of interchangeable handpieces. These accessories are designed to facilitate various treatment conditions, allowing the clinician to adapt the laser output to specific procedural requirements.

What is the regulatory status of the Helios III?

The Helios III has received FDA 510k clearance under the product code GEX. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices for its intended use.

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: Helios III — LASEROPTEK, LASEROPTEK, Helios III — LASEROPTEK, HELIOS III User Manual Rev.3 HELIOS III User… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Laseroptek Co., Ltd
FDA Applicant
Laseroptek Co., Ltd.

Sources (1)

  • FDA 510(k) K152856 24 fields · synced Sep 27, 2026