FDA 510(k)

Sistema APVolution

Número K: K163228 · 2017-06-05

Data da decisão2017-06-05

Código do produtoEIH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

APVolution System is the device name listed in this FDA 510(k) record. The listed applicant is Aesthetic-Press, LLC. It received FDA 510(k) clearance on 2017-06-05 under 510(k) number K163228. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the APVolution System?

APVolution System is a medical device that received FDA 510(k) clearance on 2017-06-05. The listed applicant is Aesthetic-Press, LLC. The 510(k) number is K163228.

When did APVolution System receive FDA 510(k) clearance?

APVolution System received FDA 510(k) clearance on 2017-06-05, under 510(k) number K163228.

Who is the listed applicant for APVolution System?

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

What is the FDA product code for APVolution System?

The FDA product code for APVolution System is EIH.

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