FDA 510(k)

Define RF Microneedling System

Número K: K232301 · 2024-03-14

Data da decisão2024-03-14

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Define RF Microneedling System is the device name listed in this FDA 510(k) record. The listed applicant is Aesthetic Management Partners. It received FDA 510(k) clearance on 2024-03-14 under 510(k) number K232301. 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 Define RF Microneedling System?

Define RF Microneedling System is a medical device that received FDA 510(k) clearance on 2024-03-14. The listed applicant is Aesthetic Management Partners. The 510(k) number is K232301.

When did Define RF Microneedling System receive FDA 510(k) clearance?

Define RF Microneedling System received FDA 510(k) clearance on 2024-03-14, under 510(k) number K232301.

Who is the listed applicant for Define RF Microneedling System?

The FDA 510(k) record lists Aesthetic Management Partners as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Define RF Microneedling System?

The FDA product code for Define RF Microneedling System is GEI.

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