510(k) Report

Devices descending from K960036

440 later devices reach Firard II/ TDP Lamp through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K241642Diode Laser Hair Removal System (MBT-Diode Laser)Beijing Mega Beauty Technology Co., Ltd.20240—
+10K231971Deka Physiq 360El.En S.P.A.20230—
+10K230467BTL-899FBTL Industries, Inc.20231—
+10K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+10K222790F65 Laser SystemLumenis Be, Ltd.20233—
+10K222221Deka HelixEl.En Electronic Engineering Spa20231—
+10K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+10K221427V-LaserWontech Co., Ltd.20222—
+10K220381Diode Laser Therapy SystemsBeijing Lasertell Medical Co., Ltd.20221—
+10K220103LED Therapy Device (Planar LED/Planar LED mini)Shenzhen Leaflife Technology Co., Ltd.20221—
+10K210168Diode Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20214—
+10K210663Dermatological Diode Laser SystemsBeijing HuaCheng Taike Technology Co., Ltd.20218—
+10K210033Laser Treatment System, Model: NYX and GraceCanadian Pioneer Medical Technology Corporation20211—
+10K192735Diode Laser Hair Removal MachineBeijing Lead Beauty S & T Co., Ltd.20202—
+10K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+10K182741SculpSureCynosure20195—
+10K162781Magma SparkFormatk Systems, Ltd.20160—
+11K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+11K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.20260—
+11K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+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—
+11K233849BTL-499BTL Industries, Inc.20240—
+11K232709Diode laser therapy deviceHebei Zhemai Technology Co., Ltd.20231—
+11K231901Hakon, Hakon SmartMedical San Indústria DE Equipamentos Médicos Ltda.20230—
+11K230362Planar LED mateShenzhen Leaflife Technology Co., Ltd.20230—
+11K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+11K221312Diode Laser Hair Removal DeviceGuangzhou Chuang Zao Mei Technology Co., Ltd.20224—
+11K212978Diode laser therapy systemBeijing Unt Technology Co., Ltd.20211—
+11K212793Laser Treatment System, Model: Hera, ArmoCanadian Pioneer Medical Technology Corporation20210—
+12K260307Diode Laser Therapy Systems (V19)Weifang Mingliang Electronics Co., Ltd.20260—
+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—
+13K252048808nm semiconductor laser hair removal machineXi'An Taibo Electronic Technology Co., Ltd.20260—