Bilicocoon™ Phototherapy System

Unit, Neonatal Phototherapy

NEOMEDLIGHT

The following data is part of a premarket notification filed by Neomedlight with the FDA for Bilicocoon™ Phototherapy System.

Pre-market Notification Details

• Device ID: K163526
• 510k Number: K163526
• Device Name: Bilicocoon™ Phototherapy System
• Classification: Unit, Neonatal Phototherapy
• Applicant: NEOMEDLIGHT 89-90 Rue Frederic FAYS Villeurbanne, FR 69100
• Contact: Pierre Saint Girons
• Correspondent: Pierre Saint Girons; NEOMEDLIGHT 89-90 Rue Frederic FAYS Villeurbanne, FR 69100
• Product Code: LBI
• CFR Regulation Number: 880.5700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-12-16
• Decision Date: 2017-10-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03760012570119	K163526	000
03760012570096	K163526	000
03760012570065	K163526	000
03760012570058	K163526	000
03760012570027	K163526	000
03760012570010	K163526	000
03760012570003	K163526	000