510(k) Report

Devices descending from K970432

323 later devices reach Infant Radiant Warmer - Models IW910 and IW920 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+11K251457Diode laser therapy device (VADER)Beijing Superlaser Technology Co., Ltd.20250—
+11K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+11K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+11K242349FoLixLumenis Be, Ltd.20240—
+11K232709Diode laser therapy deviceHebei Zhemai Technology Co., Ltd.20231—
+11K231901Hakon, Hakon SmartMedical San Indústria DE Equipamentos Médicos Ltda.20230—
+11K231971Deka Physiq 360El.En S.P.A.20230—
+11K230362Planar LED mateShenzhen Leaflife Technology Co., Ltd.20230—
+11K221312Diode Laser Hair Removal DeviceGuangzhou Chuang Zao Mei Technology Co., Ltd.20224—
+11K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+11K212978Diode laser therapy systemBeijing Unt Technology Co., Ltd.20211—
+11K212793Laser Treatment System, Model: Hera, ArmoCanadian Pioneer Medical Technology Corporation20210—
+11K182741SculpSureCynosure20195—
+12K260307Diode Laser Therapy Systems (V19)Weifang Mingliang Electronics Co., Ltd.20260—
+12K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+12K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+12K251801Diode laser device (BM091)Hebei Newangie Technology Co., Ltd.20250—
+12K250431Medical Diode Laser Hair Removal System (MNLT-D1)Shandong Moonlight Electronics Tech Co., Ltd.20251—
+12K243465Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device…Guangzhou Chuang Zao Mei Technology Co., Ltd.20250—
+12K241498Diode laser Treatment System (K18)Hebei Keylaser Sci-Tech Co.,Ltd20240—
+12K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+13K252048808nm semiconductor laser hair removal machineXi'An Taibo Electronic Technology Co., Ltd.20260—