LBI

Unit, Neonatal Phototherapy

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)

Last three years. Most recent: 2026-01-15.

NumberDecision dateApplicantDevice nameSummary
K2513082026-01-15Thera B Medical ProductsSnugLit(TM) Wearable Phototherapy System (SNGL-01-US…PDF
K2433722025-05-29Gerium Medical, Ltd.BiliWrapPDF

2 summaries are archived here for direct download.

Official FDA classification page: LBI
Classification and pathway per current FDA publications. Data from openFDA (CC0).