LBI
- Product code
- LBI
- Device name
- Unit, Neonatal Phototherapy
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5700
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 71 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251308 | 2026-01-15 | Thera B Medical Products | SnugLit(TM) Wearable Phototherapy System (SNGL-01-US… | |
| K243372 | 2025-05-29 | Gerium Medical, Ltd. | BiliWrap |
Official FDA classification page: LBI
Classification and pathway per current FDA publications. Data from openFDA (CC0).