FDA 510(k)

Intense Pulsed Light Therapy Device (MMABM-1)

Número K: K251545 · 2025-09-04

RequerenteMicowey Medical Equipment (Guangxi) Co., Ltd.

Data da decisão2025-09-04

Código do produtoONF

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Intense Pulsed Light Therapy Device (MMABM-1) is the device name listed in this FDA 510(k) record. The listed applicant is Micowey Medical Equipment (Guangxi) Co., Ltd.. It received FDA 510(k) clearance on 2025-09-04 under 510(k) number K251545. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Intense Pulsed Light Therapy Device (MMABM-1)?

Intense Pulsed Light Therapy Device (MMABM-1) is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is Micowey Medical Equipment (Guangxi) Co., Ltd.. The 510(k) number is K251545.

When did Intense Pulsed Light Therapy Device (MMABM-1) receive FDA 510(k) clearance?

Intense Pulsed Light Therapy Device (MMABM-1) received FDA 510(k) clearance on 2025-09-04, under 510(k) number K251545.

Who is the listed applicant for Intense Pulsed Light Therapy Device (MMABM-1)?

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

What is the FDA product code for Intense Pulsed Light Therapy Device (MMABM-1)?

The FDA product code for Intense Pulsed Light Therapy Device (MMABM-1) is ONF.

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Dispositivos Relacionados (Código: ONF)

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