510(k) Report

Devices descending from K982636

322 later devices reach Patient Warmer- Model PW810 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K251457Diode laser therapy device (VADER)Beijing Superlaser Technology Co., Ltd.20250—
+10K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+10K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+10K242349FoLixLumenis Be, Ltd.20240—
+10K232709Diode laser therapy deviceHebei Zhemai Technology Co., Ltd.20231—
+10K231901Hakon, Hakon SmartMedical San Indústria DE Equipamentos Médicos Ltda.20230—
+10K231971Deka Physiq 360El.En S.P.A.20230—
+10K230362Planar LED mateShenzhen Leaflife Technology Co., Ltd.20230—
+10K221312Diode Laser Hair Removal DeviceGuangzhou Chuang Zao Mei Technology Co., Ltd.20224—
+10K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+10K212978Diode laser therapy systemBeijing Unt Technology Co., Ltd.20211—
+10K212793Laser Treatment System, Model: Hera, ArmoCanadian Pioneer Medical Technology Corporation20210—
+10K182741SculpSureCynosure20195—
+11K260307Diode Laser Therapy Systems (V19)Weifang Mingliang Electronics Co., Ltd.20260—
+11K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+11K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+11K251801Diode laser device (BM091)Hebei Newangie Technology Co., Ltd.20250—
+11K250431Medical Diode Laser Hair Removal System (MNLT-D1)Shandong Moonlight Electronics Tech Co., Ltd.20251—
+11K243465Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device…Guangzhou Chuang Zao Mei Technology Co., Ltd.20250—
+11K241498Diode laser Treatment System (K18)Hebei Keylaser Sci-Tech Co.,Ltd20240—
+11K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+12K252048808nm semiconductor laser hair removal machineXi'An Taibo Electronic Technology Co., Ltd.20260—