Bilicocoon Phototherapy System— 510(k) K163526

Substantially Equivalent

Neomedlight

FDA 510(k) clearance K163526 for Bilicocoon Phototherapy System, Substantially Equivalent on 2017-10-06. Applicant: Neomedlight. Device class: 2.

Clearance details

Applicant: Neomedlight
Product code: Code LBI
Device class: Class 2
Regulation: 21 CFR 880.5700
Advisory panel: General Hospital
Date received: 2016-12-16
Decision date: 2017-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Villeurbanne, FR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.