FDA 510(k)

The Alma Opus System, Colibri Applicator and Tips

Número K: K201520 · 2021-10-27

Data da decisão2021-10-27

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

The Alma Opus System, Colibri Applicator and Tips is the device name listed in this FDA 510(k) record. The listed applicant is Alma Lasers, Inc.. It received FDA 510(k) clearance on 2021-10-27 under 510(k) number K201520. 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 Alma Opus System, Colibri Applicator and Tips?

The Alma Opus System, Colibri Applicator and Tips is a medical device that received FDA 510(k) clearance on 2021-10-27. The listed applicant is Alma Lasers, Inc.. The 510(k) number is K201520.

When did The Alma Opus System, Colibri Applicator and Tips receive FDA 510(k) clearance?

The Alma Opus System, Colibri Applicator and Tips received FDA 510(k) clearance on 2021-10-27, under 510(k) number K201520.

Who is the listed applicant for The Alma Opus System, Colibri Applicator and Tips?

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

What is the FDA product code for The Alma Opus System, Colibri Applicator and Tips?

The FDA product code for The Alma Opus System, Colibri Applicator and Tips is GEI.

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Fonte oficial

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