510(k) Report

Devices descending from K051869

17 later devices reach Neoblue Cozy Led Phototherapy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170585SkylifeNeolight, LLC20170—
+1K103589Neoblue Blanket Led Phototherapy SystemNatus Medical Incorporated201123
+1K070180Wallaby 4Respironics Inc., Sleep & Home Respiratory Group200712—
+2K200031Neonatal Phototherapy SystemAvalon Biomedical (Shenzhen) Limited20200—
+2K182178neoBLUE blanket LED Phototherapy SystemNatus Medical Incorporated20180—
+2K163526Bilicocoon™ Phototherapy SystemNeomedlight20170—
+2K111547Bili-Therapy Pad TypeAtom Medical Corporation20120—
+2K103828Bili-Therapy Spot TypeAtom Medical Corporation20112—
+2K072035Resolve Uvb Phototherapy SystemAllux Medical20076—
+3K170489Skylit Phototherapy SystemSkylit Medical20175—
+3K160238Airborne Phototherapy LightInternational Biomedical20160—
+3K142332BT-400Bio-Med USA20150—
+4K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLC20260—
+4K173436Luma Light SystemLuma Therapeutics20183—
+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—