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FDA 510(k)

DIODE LASER THERAPY SYSTEMS

Número K: K152898 · 2016-02-09

RequerenteBeijing Sincoheren Science and Tech. Development Co., Ltd.
Data da decisão2016-02-09
Código do produtoGEX
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

DIODE LASER THERAPY SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Sincoheren Science and Tech. Development Co., Ltd.. It received FDA 510(k) clearance on 2016-02-09 under 510(k) number K152898. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DIODE LASER THERAPY SYSTEMS?

DIODE LASER THERAPY SYSTEMS is a medical device that received FDA 510(k) clearance on 2016-02-09. The listed applicant is Beijing Sincoheren Science and Tech. Development Co., Ltd.. The 510(k) number is K152898.

When did DIODE LASER THERAPY SYSTEMS receive FDA 510(k) clearance?

DIODE LASER THERAPY SYSTEMS received FDA 510(k) clearance on 2016-02-09, under 510(k) number K152898.

Who is the listed applicant for DIODE LASER THERAPY SYSTEMS?

The FDA 510(k) record lists Beijing Sincoheren Science and Tech. Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIODE LASER THERAPY SYSTEMS?

The FDA product code for DIODE LASER THERAPY SYSTEMS is GEX. This falls under the Gastroenterology category.

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