FDA 510(k)

Profound Matrix

Número K: K211217 · 2021-12-16

Data da decisão2021-12-16

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Profound Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Candela Corporation. It received FDA 510(k) clearance on 2021-12-16 under 510(k) number K211217. 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 Profound Matrix?

Profound Matrix is a medical device that received FDA 510(k) clearance on 2021-12-16. The listed applicant is Candela Corporation. The 510(k) number is K211217.

When did Profound Matrix receive FDA 510(k) clearance?

Profound Matrix received FDA 510(k) clearance on 2021-12-16, under 510(k) number K211217.

Who is the listed applicant for Profound Matrix?

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

What is the FDA product code for Profound Matrix?

The FDA product code for Profound Matrix is GEI.

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Fonte oficial

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