FDA 510(k)

Fiber Laser Treatment System

Número K: K221770 · 2022-10-13

RequerenteShanghai Apolo Medical Technology Co., Ltd.

Data da decisão2022-10-13

Código do produtoONG

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fiber Laser Treatment 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 2022-10-13 under 510(k) number K221770. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Fiber Laser Treatment System?

Fiber Laser Treatment System is a medical device that received FDA 510(k) clearance on 2022-10-13. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K221770.

When did Fiber Laser Treatment System receive FDA 510(k) clearance?

Fiber Laser Treatment System received FDA 510(k) clearance on 2022-10-13, under 510(k) number K221770.

Who is the listed applicant for Fiber Laser Treatment 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 Fiber Laser Treatment System?

The FDA product code for Fiber Laser Treatment System is ONG.

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Outros registros que listam Shanghai Apolo Medical Technology Co., Ltd. como candidato(a)

K260256Q-Switched Nd: YAG Laser Systems K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)K251031Fiber Laser Treatment Systems (HS-232,HS-233)K232409Electromagnetic Stimulation Systems K203395Platform treatment system K201731Diode Laser Body Sculpture System

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Dispositivos Relacionados (Código: ONG)

K252155AVAVA™ Sistema de Tratamento de PeleAVAVA, Inc.K244060eCO2 3DLutronic Corporation K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.K250402AVAVA™ Sistema de Tratamento de PeleAVAVA, Inc.K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic K223871Miria Skin Treatment SystemAVAVA, Inc.

Fonte oficial

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