# K120168: Lullaby Led Phottherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Wipro GE Healthcare Private, Ltd.
- Decided: May 2, 2012 after 104 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 K040853 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071828: Lullaby, Ge Healthcare Clinical Systems (2007) Summary page 1.

## Indications for use
The Lullaby™ LED Phototherapy System is used for the treatment of indirect hyper-bilirubinemia in term and pre-term infants, in a hospital environment - NICUs, PICUs and Well-baby Nurseries - administered by trained, professional medical staff, on the order of a licensed medical practitioner. The Lullaby™ LED Phototherapy System is intended for use under the direct supervision of a licensed healthcare practitioner. The Lullaby™ LED Phototherapy System device is not intended to be operated in mobile vehicles including ambulances or other vehicles associated with health care facilities.

Source page: https://510kreport.com/device/K120168
Methodology: https://510kreport.com/methodology