FDA 510(k)

Clear Bi-Light

Número K: K153081 · 2016-02-15

Data da decisão2016-02-15

Código do produtoOLP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Clear Bi-Light is the device name listed in this FDA 510(k) record. The listed applicant is Michael Todd, LP. It received FDA 510(k) clearance on 2016-02-15 under 510(k) number K153081. 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 Clear Bi-Light?

Clear Bi-Light is a medical device that received FDA 510(k) clearance on 2016-02-15. The listed applicant is Michael Todd, LP. The 510(k) number is K153081.

When did Clear Bi-Light receive FDA 510(k) clearance?

Clear Bi-Light received FDA 510(k) clearance on 2016-02-15, under 510(k) number K153081.

Who is the listed applicant for Clear Bi-Light?

The FDA 510(k) record lists Michael Todd, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clear Bi-Light?

The FDA product code for Clear Bi-Light is OLP.

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