FDA 510(k)

Dispositivo de Eliminación del Vello con Láser Diódico

N.º K: K180353 · 2018-04-17

SolicitanteZhengzhou PZ Laser Slim Technology Co., Ltd.

Fecha de decisión2018-04-17

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Diode laser hair removal device is the device name listed in this FDA 510(k) record. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-04-17 under 510(k) number K180353. 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 Diode laser hair removal device?

Diode laser hair removal device is a medical device that received FDA 510(k) clearance on 2018-04-17. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. The 510(k) number is K180353.

When did Diode laser hair removal device receive FDA 510(k) clearance?

Diode laser hair removal device received FDA 510(k) clearance on 2018-04-17, under 510(k) number K180353.

Who is the listed applicant for Diode laser hair removal device?

The FDA 510(k) record lists Zhengzhou PZ Laser Slim Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diode laser hair removal device?

The FDA product code for Diode laser hair removal device is GEX. This falls under the Gastroenterology category.

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Otros registros que enlistan a Zhengzhou PZ Laser Slim Technology Co., Ltd. como solicitante

K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)K252732Sistema de Laser de Tio Aluminio a 1927nm (PZ-DJG75-01, PZ-DJG75-02)K251339Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)

Ver todos los 10 dispositivos →

Dispositivos relacionados (Código: GEX)

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.