# K053568: Bilisoft Phototherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Lumitex, Inc.
- Decided: Apr 17, 2006 after 116 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ohmieda Medical, a division of Datex-Ohnieda - BiliBlanket Plus High Output Phototherapy System: named in the summary without a submission number
- (no number) Natus - neoBLUE LED Phototherapy: named in the summary without a submission number
- (no number) Medela - Bili Phototherapy Unit: named in the summary without a submission number

## Most influential descendants
- K103589: Neoblue Blanket Led Phototherapy System (2011), 2 descendants of its own
- K123411: Little Angels Swaddling Blanket (2013), 1 descendant of its own
- K182178: neoBLUE blanket LED Phototherapy System (2018), 0 descendants of its own
- K163526: Bilicocoon™ Phototherapy System (2017), 0 descendants of its own
- K142416: Luma Wrap (2015), 0 descendants of its own

## Indications for use
The BiliSofi Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly know as neonatal jaundice, during the newborn period in the hospital or home setting. The BiliSoft Phototherapy System emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia.

Source page: https://510kreport.com/device/K053568
Methodology: https://510kreport.com/methodology