# K200031: Neonatal Phototherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Avalon Biomedical (Shenzhen) Limited
- Decided: Oct 5, 2020 after 272 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: 4 generations back to K940996 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070180: Wallaby 4, Respironics Inc., Sleep & Home Respiratory Group (2007) Summary page 4.

## Indications for use
The Neonatal Phototherapy System, Model: KANGALITE is intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates: gestational age >38 weeks and weight within 2500-4500 grams. It can be used in the clinical setting or in the home environment. It should be used for neonates whom phototherapy has been prescribed. Contraindication The Neonatal Phototherapy System, Model: KANGALITE should NOT be used in cases of: (a) Congenital porphyria or a family history of porphyria (b) Concomitant use of drugs or agents that are photosensitizers A use that does not take into account these contraindications may lead to an ineffective treatment or to potential risks to the patient’s health.

Source page: https://510kreport.com/device/K200031
Methodology: https://510kreport.com/methodology