SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)

FDA 510(k) K251308 · Thera B Medical Products

Substantially Equivalent

510(k) numberK251308

Submission

Device name
SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)
Applicant
Thera B Medical Products
East Lansing, MI, US
Received
April 28, 2025
Decision date
January 15, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LBI – Unit, Neonatal Phototherapy
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5700
Specialty
General Hospital

Other 510(k)s with product code LBI

510(k)DeviceApplicantDecision
K243372BiliWrapLBI · Traditional Gerium Medical, Ltd.05/29/2025SE
K210289Infant Phototherapy EquipmentLBI · Traditional Bistos Co., Ltd.05/28/2021SE
K200031Neonatal Phototherapy SystemLBI · Traditional Avalon Biomedical (Shenzhen) Limited10/05/2020SE
K190899bili-hutLBI · Traditional Little Sparrows Technologies, Inc.09/05/2019SE
K182178neoBLUE blanket LED Phototherapy SystemLBI · Traditional Natus Medical Incorporated12/13/2018SE
K172656BiliLuxLBI · Traditional Draeger Medical Systems, Inc.05/01/2018SE
K170585SkylifeLBI · Traditional Neolight, LLC10/27/2017SE
K163526Bilicocoon™ Phototherapy SystemLBI · Traditional Neomedlight10/06/2017SE
K160745neoBLUE compact LED Phototherapy SystemLBI · Traditional Natus Medical Incorporated12/12/2016SE
K160238Airborne Phototherapy LightLBI · Abbreviated International Biomedical06/14/2016SE

Questions and answers

When was SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) cleared by the FDA?

SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) (K251308) received a 510(k) decision of Substantially Equivalent on January 15, 2026, 262 days after the submission was received.

What is the product code of K251308?

The FDA product code is LBI – Unit, Neonatal Phototherapy, a Class II (moderate risk) device regulated under 21 CFR 880.5700.