DeviceClearance

Product code LBI— General Hospital

PRECIOUS LITE MODEL 4224

Classification name
Unit, Neonatal Phototherapy
Device class
Class 2
Regulation
21 CFR 880.5700
Advisory panel
General Hospital
Total cleared
71
First cleared
Most recent

Market context for product code LBI

FDA has cleared 71 devices under product code LBI between 1976 and 2026, filed by 45 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code LBI

Recent clearances under product code LBI

Data sourced from openFDA. This site is unofficial and independent of the FDA.