# K040853: Phoenix Phototherapy Unit CFL, Model 101

- Pathway: 510(k) (Traditional)
- Applicant: International Hospital Supply Co.
- Decided: Jun 21, 2004 after 81 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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 no predicate by number.

## Most influential descendants
- K071828: Lullaby (2007), 1 descendant of its own
- K120168: Lullaby Led Phottherapy System (2012), 0 descendants of its own

## Indications for use
The PHOENIX Neonatal Phototherapy Unit CFL 101 provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital.

Source page: https://510kreport.com/device/K040853
Methodology: https://510kreport.com/methodology