FDA 510(k)

The Evolve System with the Transform Applicator

Número K: K231495 · 2023-10-13

Data da decisão2023-10-13

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

The Evolve System with the Transform Applicator is the device name listed in this FDA 510(k) record. The listed applicant is InMode , Ltd.. It received FDA 510(k) clearance on 2023-10-13 under 510(k) number K231495. 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 The Evolve System with the Transform Applicator?

The Evolve System with the Transform Applicator is a medical device that received FDA 510(k) clearance on 2023-10-13. The listed applicant is InMode , Ltd.. The 510(k) number is K231495.

When did The Evolve System with the Transform Applicator receive FDA 510(k) clearance?

The Evolve System with the Transform Applicator received FDA 510(k) clearance on 2023-10-13, under 510(k) number K231495.

Who is the listed applicant for The Evolve System with the Transform Applicator?

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

What is the FDA product code for The Evolve System with the Transform Applicator?

The FDA product code for The Evolve System with the Transform Applicator is GEI.

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Fonte oficial

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