# K251308: SnugLit (TM) Wearable Phototherapy System (SNGL-01-US)

- Pathway: 510(k) (Traditional)
- Applicant: Thera B Medical Products
- Decided: Jan 15, 2026 after 262 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 K883779 (1988). 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)
- K210289: Infant Phototherapy Equipment, Bistos Co., Ltd. (2021) Summary page 5.

## Indications for use
The SnugLit(TM) Wearable Phototherapy System is intended for use in the treatment of infant hyperbilirubinemia, commonly known as neonatal jaundice. The device can be used in a hospital or at home, by a licensed medical practitioner or by a caregiver under the supervision of a licensed medical practitioner. The device has been designed for use with infants of weights between 1.5 – 5.5 kg (approximately 3.5 -12 lbs) and lengths between 40.5 - 57.5 cm (approximately 16 - 23 inches).

Source page: https://510kreport.com/device/K251308
Methodology: https://510kreport.com/methodology