FDA 510(k)

CO2 Laser Therapy Machine

Número K: K161925 · 2016-10-05

RequerenteBeijing Adss Development Co., Ltd.

Data da decisão2016-10-05

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

CO2 Laser Therapy Machine is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Adss Development Co., Ltd.. It received FDA 510(k) clearance on 2016-10-05 under 510(k) number K161925. 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 CO2 Laser Therapy Machine?

CO2 Laser Therapy Machine is a medical device that received FDA 510(k) clearance on 2016-10-05. The listed applicant is Beijing Adss Development Co., Ltd.. The 510(k) number is K161925.

When did CO2 Laser Therapy Machine receive FDA 510(k) clearance?

CO2 Laser Therapy Machine received FDA 510(k) clearance on 2016-10-05, under 510(k) number K161925.

Who is the listed applicant for CO2 Laser Therapy Machine?

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

What is the FDA product code for CO2 Laser Therapy Machine?

The FDA product code for CO2 Laser Therapy Machine is GEX. This falls under the Gastroenterology category.

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Outros registros que listam Beijing Adss Development Co., Ltd. como candidato(a)

K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)K233307Intensity Pulsed Light Therapy System K231896Diode Laser Therapy System K231318Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)K220268Picosecond Laser System (Model PS10-A and PS10-B)K192295PDT-FACE

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Fonte oficial

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