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FDA 510(k)

NIRA Model 2

N.º K: K222685 · 2023-02-08

SolicitanteDermal Photonics Corp
Fecha de decisión2023-02-08
Código de productoOHS
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

NIRA Model 2 is the device name listed in this FDA 510(k) record. The listed applicant is Dermal Photonics Corp. It received FDA 510(k) clearance on 2023-02-08 under 510(k) number K222685. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the NIRA Model 2?

NIRA Model 2 is a medical device that received FDA 510(k) clearance on 2023-02-08. The listed applicant is Dermal Photonics Corp. The 510(k) number is K222685.

When did NIRA Model 2 receive FDA 510(k) clearance?

NIRA Model 2 received FDA 510(k) clearance on 2023-02-08, under 510(k) number K222685.

Who is the listed applicant for NIRA Model 2?

The FDA 510(k) record lists Dermal Photonics Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIRA Model 2?

The FDA product code for NIRA Model 2 is OHS.

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Fuente oficial

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