FDA 510(k)

Bilicocoon™ Phototherapy System

Número K: K163526 · 2017-10-06

Data da decisão2017-10-06

Código do produtoLBI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Bilicocoon™ Phototherapy System is the device name listed in this FDA 510(k) record. The listed applicant is Neomedlight. It received FDA 510(k) clearance on 2017-10-06 under 510(k) number K163526. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Bilicocoon™ Phototherapy System?

Bilicocoon™ Phototherapy System is a medical device that received FDA 510(k) clearance on 2017-10-06. The listed applicant is Neomedlight. The 510(k) number is K163526.

When did Bilicocoon™ Phototherapy System receive FDA 510(k) clearance?

Bilicocoon™ Phototherapy System received FDA 510(k) clearance on 2017-10-06, under 510(k) number K163526.

Who is the listed applicant for Bilicocoon™ Phototherapy System?

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

What is the FDA product code for Bilicocoon™ Phototherapy System?

The FDA product code for Bilicocoon™ Phototherapy System is LBI.

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