FDA 510(k)

Luma Light System

Número K: K173436 · 2018-01-30

Data da decisão2018-01-30

Código do produtoFTC

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Luma Light System is the device name listed in this FDA 510(k) record. The listed applicant is Luma Therapeutics. It received FDA 510(k) clearance on 2018-01-30 under 510(k) number K173436. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Luma Light System?

Luma Light System is a medical device that received FDA 510(k) clearance on 2018-01-30. The listed applicant is Luma Therapeutics. The 510(k) number is K173436.

When did Luma Light System receive FDA 510(k) clearance?

Luma Light System received FDA 510(k) clearance on 2018-01-30, under 510(k) number K173436.

Who is the listed applicant for Luma Light System?

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

What is the FDA product code for Luma Light System?

The FDA product code for Luma Light System is FTC.

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