Clearance Summary
SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) received FDA 510(k) clearance under submission number K251308, sponsored by Thera B Medical Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2026-01-15.
- Submission: K251308
- Applicant / Sponsor: Thera B Medical Products
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5700
- Decision date: 2026-01-15
Classification & Regulation
This clearance is catalogued under FDA product code LBI and 21 CFR 880.5700, within the General Hospital review panel as a Class II device.