510(k) Report

Devices descending from K940996

30 later devices reach Olympic Bili-Lite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022196Natus Blue Light Phototherapy UnitNatus Medical, Inc.2002295
+2K160305neoBLUE® LED Phototherapy SystemNatus Medical Incorporated20160—
+2K113206Nanoblutm 500Draeger Medical Systems, Inc.20123—
+2K103735Mediled MiniMedix I.C.S.A.20111—
+2K083179Mediled Phototherapy LampMedix I.C.S.A.20092—
+2K072097Bilibee Led Phototherapy System, Model: 1Medical Select, Inc.20073—
+2K072035Resolve Uvb Phototherapy SystemAllux Medical20076—
+2K070180Wallaby 4Respironics Inc., Sleep & Home Respiratory Group200712—
+2K051869Neoblue Cozy Led Phototherapy SystemNatus Medical, Inc.200517—
+3K210289Infant Phototherapy EquipmentBistos Co., Ltd.20212—
+3K200031Neonatal Phototherapy SystemAvalon Biomedical (Shenzhen) Limited20200—
+3K172656BiliLuxDraeger Medical Systems, Inc.20180—
+3K170585SkylifeNeolight, LLC20170—
+3K170489Skylit Phototherapy SystemSkylit Medical20175—
+3K160745neoBLUE compact LED Phototherapy SystemNatus Medical Incorporated20160—
+3K160238Airborne Phototherapy LightInternational Biomedical20160—
+3K131196Infant Phototherapy Bilitron Sky 5006Fanem Lda20140—
+3K111547Bili-Therapy Pad TypeAtom Medical Corporation20120—
+3K103589Neoblue Blanket Led Phototherapy SystemNatus Medical Incorporated201123
+3K103828Bili-Therapy Spot TypeAtom Medical Corporation20112—
+4K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLC20260—
+4K251308SnugLit (TM) Wearable Phototherapy System (SNGL-01-US)Thera B Medical Products20260—
+4K243372BiliWrapGerium Medical, Ltd.20250—
+4K182178neoBLUE blanket LED Phototherapy SystemNatus Medical Incorporated20180—
+4K173436Luma Light SystemLuma Therapeutics20183—
+4K163526Bilicocoon™ Phototherapy SystemNeomedlight20170—
+4K142332BT-400Bio-Med USA20150—
+5K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+6K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+7K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—