K251308
- 510(k) number
- K251308
- Device name
- SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)
- Applicant
- Thera B Medical Products MI · US
- Product code
- LBI — Unit, Neonatal Phototherapy
- Decision date
- 2026-01-15
- Date received
- 2025-04-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K251308.pdf
Official FDA record: K251308
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.