# K120820: Giraffe Blue Spot PT Lite

- Pathway: 510(k) (Traditional)
- Applicant: Lumitex, Inc.
- Decided: Jun 8, 2012 after 81 days
- Product code: LBI (Unit, Neonatal Phototherapy)
- Device class: 2
- Regulation: 21 CFR 880.5700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011549 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011549: Ohmeda Medical Spot PT Lite Phototherapy System, Ohmeda Medical (2001) Summary page 1.

## Recalls of this device
- Dec 11, 2019 · Class II · Z-0923-2020: There is a potential for some systems built between 2014 and Jan 2018 to have a light output falling below the recommended minimum output. This problem has been associated with exposure of the light p

## Indications for use
The Giraffe Blue Spot PT Lite phototherapy system 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/K120820
Methodology: https://510kreport.com/methodology