FDA 510(k)

INTRAcel RF Microneedle System

Número K: K183284 · 2020-01-15

Data da decisão2020-01-15

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

INTRAcel RF Microneedle 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 2020-01-15 under 510(k) number K183284. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the INTRAcel RF Microneedle System?

INTRAcel RF Microneedle System is a medical device that received FDA 510(k) clearance on 2020-01-15. The listed applicant is Jeisys Medical, Inc.. The 510(k) number is K183284.

When did INTRAcel RF Microneedle System receive FDA 510(k) clearance?

INTRAcel RF Microneedle System received FDA 510(k) clearance on 2020-01-15, under 510(k) number K183284.

Who is the listed applicant for INTRAcel RF Microneedle 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 RF Microneedle System?

The FDA product code for INTRAcel RF Microneedle System is GEI.

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Fonte oficial

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