Data / Medical devices / Unit, Neonatal Phototherapy

Unit, Neonatal Phototherapy (LBI): 23 FDA-registered makers in 10 countries

23 establishments in 10 countries are registered with the FDA to make Unit, Neonatal Phototherapy (product code LBI, Class 2, 21 CFR 880.5700). 16 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 71 510(k) clearances under this code, the latest on January 15, 2026, and lists 14 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

LBI

Device class

2

Regulation

880.5700

Medical specialty

General Hospital

Makers by country

Makers of Unit, Neonatal Phototherapy

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated January 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.