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LBI — Unit, Neonatal Phototherapy Class II

FDA Device Classification

Classification Details

Product Code
LBI
Device Class
Class II
Regulation Number
880.5700
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251308thera b medical productsSnugLit(TM) Wearable Phototherapy System (SNGL-01-US)January 15, 2026
K243372gerium medicalBiliWrapMay 29, 2025
K210289bistos coInfant Phototherapy EquipmentMay 28, 2021
K200031avalon biomedical (shenzhen) limitedNeonatal Phototherapy SystemOctober 5, 2020
K190899little sparrows technologiesbili-hutSeptember 5, 2019
K182178natus medical incorporatedneoBLUE blanket LED Phototherapy SystemDecember 13, 2018
K172656draeger medical systemsBiliLuxMay 1, 2018
K170585neolightSkylifeOctober 27, 2017
K163526neomedlightBilicocoon™ Phototherapy SystemOctober 6, 2017
K160745natus medical incorporatedneoBLUE compact LED Phototherapy SystemDecember 12, 2016
K160238international biomedicalAirborne Phototherapy LightJune 14, 2016
K160305natus medical incorporatedneoBLUE® LED Phototherapy SystemMay 27, 2016
K142332bio-med usaBT-400March 20, 2015
K131196fanem ldaINFANT PHOTOTHERAPY BILITRON SKY 5006February 20, 2014
K120820lumitexGIRAFFE BLUE SPOT PT LITEJune 8, 2012
K120168wipro ge healthcare privateLULLABY LED PHOTTHERAPY SYSTEMMay 2, 2012
K111547atom medical corporationBILI-THERAPY PAD TYPEApril 12, 2012
K113206draeger medical systemsNANOBLUTM 500February 17, 2012
K110550physician engineered productsBRIGHT EMBRACE MODEL SBL60February 3, 2012
K103735medix i.cMEDILED MINIAugust 15, 2011