FDA 510(k)

INTRAcel Premium Fractional RF Micro Needle (FRM) System

N.º K: K153727 · 2016-07-21

Fecha de decisión2016-07-21

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

INTRAcel Premium Fractional RF Micro Needle (FRM) System is the device name listed in this FDA 510(k) record. The listed applicant is Jeisys Medical, Inc.. It received FDA 510(k) clearance on 2016-07-21 under 510(k) number K153727. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the INTRAcel Premium Fractional RF Micro Needle (FRM) System?

INTRAcel Premium Fractional RF Micro Needle (FRM) System is a medical device that received FDA 510(k) clearance on 2016-07-21. The listed applicant is Jeisys Medical, Inc.. The 510(k) number is K153727.

When did INTRAcel Premium Fractional RF Micro Needle (FRM) System receive FDA 510(k) clearance?

INTRAcel Premium Fractional RF Micro Needle (FRM) System received FDA 510(k) clearance on 2016-07-21, under 510(k) number K153727.

Who is the listed applicant for INTRAcel Premium Fractional RF Micro Needle (FRM) System?

The FDA 510(k) record lists Jeisys Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRAcel Premium Fractional RF Micro Needle (FRM) System?

The FDA product code for INTRAcel Premium Fractional RF Micro Needle (FRM) System is GEI.

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Fuente oficial

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