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FDA 510(k)

HairMax Laser

N.º K: K180885 · 2018-06-20

SolicitanteLexington International, LLC
Fecha de decisión2018-06-20
Código de productoOAP
Comité asesorPM
DecisiónSubstantially Equivalent

Resumen del dispositivo

HairMax Laser is the device name listed in this FDA 510(k) record. The listed applicant is Lexington International, LLC. It received FDA 510(k) clearance on 2018-06-20 under 510(k) number K180885. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the HairMax Laser?

HairMax Laser is a medical device that received FDA 510(k) clearance on 2018-06-20. The listed applicant is Lexington International, LLC. The 510(k) number is K180885.

When did HairMax Laser receive FDA 510(k) clearance?

HairMax Laser received FDA 510(k) clearance on 2018-06-20, under 510(k) number K180885.

Who is the listed applicant for HairMax Laser?

The FDA 510(k) record lists Lexington International, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HairMax Laser?

The FDA product code for HairMax Laser is OAP.

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Dispositivos relacionados (Código: OAP)

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.

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Fuente oficial

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