Cleared Traditional

K163526 - Bilicocoon Phototherapy System

K163526 is an FDA 510(k) clearance for Bilicocoon Phototherapy System, manufactured by Neomedlight. The device is a Class 2 General Hospital device with product code LBI cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K163526 · Neomedlight · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 2017
Decision
294d
Days
Class 2
Risk

K163526 is an FDA 510(k) clearance for the Bilicocoon™ Phototherapy System. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Neomedlight (Villeurbanne, FR). The FDA issued a Cleared decision on October 6, 2017 after a review of 294 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5700 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Neomedlight devices

FDA 510(k) Submission Details - K163526

510(k) Number K163526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2016
Decision Date October 06, 2017
Days to Decision 294 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 129d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBI Device Classification - Class 2, Special Controls

Product Code LBI Unit, Neonatal Phototherapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LBI Unit, Neonatal Phototherapy

All 31
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K163526.
bili-hut
K190899 · Little Sparrows Technologies, Inc. · Sep 2019
neoBLUE blanket LED Phototherapy System
K182178 · Natus Medical Incorporated · Dec 2018
BiliLux
K172656 · Draeger Medical Systems, Inc. · May 2018
NANOBLUTM 500
K113206 · Draeger Medical Systems, Inc. · Feb 2012
WALLABY 4
K070180 · Respironics Inc., Sleep & Home Respiratory Group · May 2007
OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM
K011549 · Ohmeda Medical · Jul 2001