510(k) K251308
K251308 is an FDA 510(k) premarket notification submitted by Thera B Medical Products for the device "SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)". The FDA issued a decision of Substantially Equivalent on January 15, 2026. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 15, 2026
- Date Received
- April 28, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Neonatal Phototherapy
- Device Class
- Class II
- Regulation Number
- 880.5700
- Review Panel
- HO
- Submission Type