# K110550: Bright Embrace Model SBL60

- Pathway: 510(k) (Traditional)
- Applicant: Physician Engineered Products, Inc.
- Decided: Feb 3, 2012 after 343 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 K974830 (1998). 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)
- K974830: Ultra Bili Light, Physician Engineered Products, Inc. (1998) Summary page 1.

## Recalls of this device
- Aug 31, 2013 · Class II · Z-2486-2015: Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions

## Indications for use
The Bright Embrace Model SBL6O phototherapy light is intended for the treatment of neonatal hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath and around the neonate. The Bright Embrace can be used in a clinical setting or in the home.

Source page: https://510kreport.com/device/K110550
Methodology: https://510kreport.com/methodology