510(k) K251308 ยท LBI Unit, Neonatal Phototherapy
SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)
| Applicant | Thera B Medical Products, East Lansing MI, US |
| Decision | Substantially Equivalent, Jan 15, 2026 |
| Received | Apr 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251308
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.