# K170585: Skylife

- Pathway: 510(k) (Traditional)
- Applicant: Neolight, LLC
- Decided: Oct 27, 2017 after 241 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: 3 generations back to K940996 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051869: Neoblue Cozy Led Phototherapy System, Natus Medical, Inc. (2005) Summary page 4.
- K011549: Ohmeda Medical Spot PT Lite Phototherapy System, Ohmeda Medical (2001) Summary page 4.

## Indications for use
Skylife™ is intended for the treatment of neonatal unconjugated hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath the baby. Skylife™ must be used within a patient enclosure, such as a bassinet, an open crib, a warming table or an incubator. Skylife™ can be used in a clinical setting or in the home.

Source page: https://510kreport.com/device/K170585
Methodology: https://510kreport.com/methodology