K251308 is an FDA 510(k) clearance for the SnugLit(TM) Wearable Phototherapy System (SNGL-01-US). This device is classified as 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 FDA review panel. Regulated under 21 CFR 880.5700.
| 510(k) Number | K251308 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | LBI - Unit, Neonatal Phototherapy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5700 |