# K163526: Bilicocoon™ Phototherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Neomedlight
- Decided: Oct 6, 2017 after 294 days
- Product code: LBI (Unit, Neonatal Phototherapy)
- Device class: 2
- Regulation: 21 CFR 880.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K940996 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103589: Neoblue Blanket Led Phototherapy System, Natus Medical Incorporated (2011) Summary page 4.

## Indications for use
The BiliCocoon™ Phototherapy System is intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates and infants under 3 months old and weighing less than 10kg. It can be used in the clinical setting or in the home

Source page: https://510kreport.com/device/K163526
Methodology: https://510kreport.com/methodology