510(k) Report

Devices descending from K991627

17 later devices reach Wallaby 3 Phototherapy System, Model 3600 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072097Bilibee Led Phototherapy System, Model: 1Medical Select, Inc.20073—
+1K070180Wallaby 4Respironics Inc., Sleep & Home Respiratory Group200712—
+2K210289Infant Phototherapy EquipmentBistos Co., Ltd.20212—
+2K200031Neonatal Phototherapy SystemAvalon Biomedical (Shenzhen) Limited20200—
+2K111547Bili-Therapy Pad TypeAtom Medical Corporation20120—
+2K103828Bili-Therapy Spot TypeAtom Medical Corporation20112—
+2K072035Resolve Uvb Phototherapy SystemAllux Medical20076—
+3K251308SnugLit (TM) Wearable Phototherapy System (SNGL-01-US)Thera B Medical Products20260—
+3K243372BiliWrapGerium Medical, Ltd.20250—
+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—