FDA 510(k)

The InMode System with the Morpheus8 Applicators

Número K: K231790 · 2023-07-20

Data da decisão2023-07-20

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

The InMode System with the Morpheus8 Applicators is the device name listed in this FDA 510(k) record. The listed applicant is InMode , Ltd.. It received FDA 510(k) clearance on 2023-07-20 under 510(k) number K231790. 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 InMode System with the Morpheus8 Applicators?

The InMode System with the Morpheus8 Applicators is a medical device that received FDA 510(k) clearance on 2023-07-20. The listed applicant is InMode , Ltd.. The 510(k) number is K231790.

When did The InMode System with the Morpheus8 Applicators receive FDA 510(k) clearance?

The InMode System with the Morpheus8 Applicators received FDA 510(k) clearance on 2023-07-20, under 510(k) number K231790.

Who is the listed applicant for The InMode System with the Morpheus8 Applicators?

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 InMode System with the Morpheus8 Applicators?

The FDA product code for The InMode System with the Morpheus8 Applicators is GEI.

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Fonte oficial

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