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FDA 510(k)

Intense Pulsed Light Therapy Device (MMABM-1)

N.º K: K251545 · 2025-09-04

SolicitanteMicowey Medical Equipment (Guangxi) Co., Ltd.
Fecha de decisión2025-09-04
Código de productoONF
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

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Dispositivos relacionados (Código: ONF)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.K231952MEDILIGHTMedicreations, LLCK243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.K250281DEKA LOTUSEl.En S.P.A.K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.K240314MULA (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.

Fuente oficial

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

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