FDA 510(k)

The Luminance RED Acne Device

Número K: K220729 · 2022-06-09

RequerenteLuminance Medical Ventures, Inc.

Data da decisão2022-06-09

Código do produtoOLP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

The Luminance RED Acne Device is the device name listed in this FDA 510(k) record. The listed applicant is Luminance Medical Ventures, Inc.. It received FDA 510(k) clearance on 2022-06-09 under 510(k) number K220729. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the The Luminance RED Acne Device?

The Luminance RED Acne Device is a medical device that received FDA 510(k) clearance on 2022-06-09. The listed applicant is Luminance Medical Ventures, Inc.. The 510(k) number is K220729.

When did The Luminance RED Acne Device receive FDA 510(k) clearance?

The Luminance RED Acne Device received FDA 510(k) clearance on 2022-06-09, under 510(k) number K220729.

Who is the listed applicant for The Luminance RED Acne Device?

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

What is the FDA product code for The Luminance RED Acne Device?

The FDA product code for The Luminance RED Acne Device is OLP.

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Outros registros que listam Luminance Medical Ventures, Inc. como candidato(a)

K251973Luminance Red Cold Sore Device (TN1927G)

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Fonte oficial

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