# K160238: Airborne Phototherapy Light

- Pathway: 510(k) (Abbreviated)
- Applicant: International Biomedical
- Decided: Jun 14, 2016 after 134 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: 5 generations back to K940996 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103828: Bili-Therapy Spot Type, Atom Medical Corporation (2011) Summary page 4.
- K113206: Nanoblutm 500, Draeger Medical Systems, Inc. (2012) Summary page 4.

## Indications for use
The Airborne Phototherapy Light System is intended to be used in one of two modes: observation light mode or phototherapy light mode. The observation light mode utilizes white light and is intended to be used as auxiliary lighting that supplements the ambient lighting. The phototherapy light mode utilizes blue light and is intended to be used in the treatment of neonatal hyperbilirubinemia.

Source page: https://510kreport.com/device/K160238
Methodology: https://510kreport.com/methodology