FDA.reportPublic FDA data

510(k) K243372

Device
BiliWrap
Applicant
Gerium Medical, Ltd.
510(k) number
K243372
Product code
LBI
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-29
Date received
2024-10-30
Regulation
880.5700
Classification name
Unit, Neonatal Phototherapy
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Noam Rubin Tal
Address
4 Paran St. Bldg. 11 Yavne IL 8122503 8122503

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LBI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251308SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)Thera B Medical Products2026-01-15
K210289Infant Phototherapy EquipmentBistos Co., Ltd.2021-05-28
K200031Neonatal Phototherapy SystemAvalon Biomedical (Shenzhen) Limited2020-10-05
K190899bili-hutLittle Sparrows Technologies, Inc.2019-09-05
K182178neoBLUE blanket LED Phototherapy SystemNatus Medical Incorporated2018-12-13
K172656BiliLuxDraeger Medical Systems, Inc.2018-05-01
K170585SkylifeNeolight, LLC2017-10-27
K163526Bilicocoon™ Phototherapy SystemNeomedlight2017-10-06
K160745neoBLUE compact LED Phototherapy SystemNatus Medical Incorporated2016-12-12
K160238Airborne Phototherapy LightInternational Biomedical2016-06-14
K160305neoBLUE® LED Phototherapy SystemNatus Medical Incorporated2016-05-27
K142332BT-400Bio-Med USA2015-03-20
K131196INFANT PHOTOTHERAPY BILITRON SKY 5006Fanem Lda2014-02-20
K120820GIRAFFE BLUE SPOT PT LITELumitex, Inc.2012-06-08
K120168LULLABY LED PHOTTHERAPY SYSTEMWipro GE Healthcare Private, Ltd.2012-05-02