510(k) Report

Devices descending from K070180

12 later devices reach Wallaby 4 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200031Neonatal Phototherapy SystemAvalon Biomedical (Shenzhen) Limited20200—
+1K111547Bili-Therapy Pad TypeAtom Medical Corporation20120—
+1K103828Bili-Therapy Spot TypeAtom Medical Corporation20112—
+1K072035Resolve Uvb Phototherapy SystemAllux Medical20076—
+2K170489Skylit Phototherapy SystemSkylit Medical20175—
+2K160238Airborne Phototherapy LightInternational Biomedical20160—
+2K142332BT-400Bio-Med USA20150—
+3K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLC20260—
+3K173436Luma Light SystemLuma Therapeutics20183—
+4K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+5K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+6K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—