FDA 510(k)

PicoSecond Nd: YAG Laser System

N.º K: K200116 · 2020-05-28

SolicitanteShanghai Apolo Medical Technology Co., Ltd.

Fecha de decisión2020-05-28

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

PicoSecond Nd: YAG Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-28 under 510(k) number K200116. 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.

Preguntas frecuentes

What is the PicoSecond Nd: YAG Laser System?

PicoSecond Nd: YAG Laser System is a medical device that received FDA 510(k) clearance on 2020-05-28. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K200116.

When did PicoSecond Nd: YAG Laser System receive FDA 510(k) clearance?

PicoSecond Nd: YAG Laser System received FDA 510(k) clearance on 2020-05-28, under 510(k) number K200116.

Who is the listed applicant for PicoSecond Nd: YAG Laser System?

The FDA 510(k) record lists Shanghai Apolo Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PicoSecond Nd: YAG Laser System?

The FDA product code for PicoSecond Nd: YAG Laser System is GEX. This falls under the Gastroenterology category.

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Otros registros que enlistan a Shanghai Apolo Medical Technology Co., Ltd. como solicitante

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Fuente oficial

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