Cleared Traditional

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

K251308 · Thera B Medical Products · General Hospital
Jan 2026
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K251308 is an FDA 510(k) clearance for the SnugLit(TM) Wearable Phototherapy System (SNGL-01-US), a Unit, Neonatal Phototherapy (Class II — Special Controls, product code LBI), submitted by Thera B Medical Products (East Lansing, US). The FDA issued a Cleared decision on January 15, 2026, 262 days after receiving the submission on April 28, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5700.

Submission Details

510(k) Number K251308 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2025
Decision Date January 15, 2026
Days to Decision 262 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LBI — Unit, Neonatal Phototherapy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5700