FDA 510(k)

Medicell Mycosis Laser (MCML24004)

N.º K: K253960 · 2026-03-09

Fecha de decisión2026-03-09

Código de productoPDZ

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Medicell Mycosis Laser (MCML24004) is the device name listed in this FDA 510(k) record. The listed applicant is Medicell Healthcare Co.,LTD. It received FDA 510(k) clearance on 2026-03-09 under 510(k) number K253960. The device is classified under product code PDZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Medicell Mycosis Laser (MCML24004)?

Medicell Mycosis Laser (MCML24004) is a medical device that received FDA 510(k) clearance on 2026-03-09. The listed applicant is Medicell Healthcare Co.,LTD. The 510(k) number is K253960.

When did Medicell Mycosis Laser (MCML24004) receive FDA 510(k) clearance?

Medicell Mycosis Laser (MCML24004) received FDA 510(k) clearance on 2026-03-09, under 510(k) number K253960.

Who is the listed applicant for Medicell Mycosis Laser (MCML24004)?

The FDA 510(k) record lists Medicell Healthcare Co.,LTD as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medicell Mycosis Laser (MCML24004)?

The FDA product code for Medicell Mycosis Laser (MCML24004) is PDZ.

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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.