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LED Spectrum Therapy Instrument

FDA 510(k)

Class II (US FDA 510(k))

510(k) K231894

by Shenzhenshi Sincoheren S&T Development Co., Ltd.

Identifiers

510(k) Number
K231894 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 LED Spectrum Therapy Instrument is a medical device classified as a light-emitting diode (LED) therapy device designed to deliver targeted light therapy for soft tissue treatment. It emits specific wavelengths of light to promote healing, reduce inflammation, and enhance tissue regeneration in plastic surgery applications.

This device is intended for use in clinical settings and has received FDA 510(k) clearance under Traditional review (K231894) with a product code of GEX under 21 CFR 878. It is supplied as a reusable instrument and is regulated under the General, Plastic Surgery advisory committee. No third-party review was involved in this submission.

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: LED Spectrum therapy instrument (K231894) — FDA 510 (k) | Innolitics, PDF Shenzhenshi Sincoheren S&T Development Co.,Ltd., K231894 - LED Spectrum therapy instrument - FDA 510 (k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhenshi Sincoheren S&T Development Co., Ltd.

Sources (1)

  • FDA 510(k) K231894 24 fields · synced Sep 19, 2026