# K072097: Bilibee Led Phototherapy System, Model: 1

- Pathway: 510(k) (Traditional)
- Applicant: Medical Select, Inc.
- Decided: Oct 30, 2007 after 91 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: 2 generations back to K883779 (1988). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022196: Natus Blue Light Phototherapy Unit, Natus Medical, Inc. (2002) Summary page 1.
- K991627: Wallaby 3 Phototherapy System, Model 3600, Respironics, Inc. (1999) Summary page 1.
- K984589: Phototherapy Lamp, Medela, Inc. (1999) Summary page 1.

## Most influential descendants
- K210289: Infant Phototherapy Equipment (2021), 2 descendants of its own
- K251308: SnugLit (TM) Wearable Phototherapy System (SNGL-01-US) (2026), 0 descendants of its own
- K243372: BiliWrap (2025), 0 descendants of its own

## Indications for use
The intended use of the BiliBee LED Phototherapy System is the treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The system can be used with off-the-self AA battery pack for portability or an AC/DC regulated power supply. The BiliBee LED Phototherapy System can be used in a hospital or at home

Source page: https://510kreport.com/device/K072097
Methodology: https://510kreport.com/methodology