FDA 510(k)

LED Phototherapy Device

Número K: K162098 · 2017-01-30

RequerenteLi-Tek Electronic Technology Corporation

Data da decisão2017-01-30

Código do produtoOLP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

LED Phototherapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Li-Tek Electronic Technology Corporation. It received FDA 510(k) clearance on 2017-01-30 under 510(k) number K162098. 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 LED Phototherapy Device?

LED Phototherapy Device is a medical device that received FDA 510(k) clearance on 2017-01-30. The listed applicant is Li-Tek Electronic Technology Corporation. The 510(k) number is K162098.

When did LED Phototherapy Device receive FDA 510(k) clearance?

LED Phototherapy Device received FDA 510(k) clearance on 2017-01-30, under 510(k) number K162098.

Who is the listed applicant for LED Phototherapy Device?

The FDA 510(k) record lists Li-Tek Electronic Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Phototherapy Device?

The FDA product code for LED Phototherapy Device is OLP.

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