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Helios IV 785

FDA 510(k)

Class II (US FDA 510(k))

510(k) K212663

by Laseroptek Co., Ltd

Identifiers

510(k) Number
K212663 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 IV 785 is a Q-switched Nd:YAG laser system designed to emit dual 1064nm and 532nm nanosecond pulses alongside 785nm picosecond pulses. It is indicated for use in tattoo removal, the treatment of benign pigmented lesions, skin brightening, and skin toning.

This device is manufactured by Laseroptek Co., Ltd. and has received FDA 510(k) clearance. It functions as a single platform that integrates both pico and nano laser technologies for clinical applications.

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 LASEROPTEK Co., Ltd. Received CE Approval for HELIOS IV 785, LASEROPTEK, Helios 785 Pico — LASEROPTEK, Helios 785 Pico — LASEROPTEK

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) K212663 24 fields · synced Sep 25, 2026