510(k) Report

Devices descending from K955612

1,548 later devices reach RD-1200H Normal Mode Ruby Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V.20227—
+12K221946LED Light Therapy Mask (model: MK66R-B)Light Tree Ventures Europe B.V.202218—
+12K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.202241—
+12K221312Diode Laser Hair Removal DeviceGuangzhou Chuang Zao Mei Technology Co., Ltd.20224—
+12K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+12K212891TempSure SystemCynosure, LLC20221—
+12K213344BTL-899ABTL Industries, Inc.20222—
+12K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin202135—
+12K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+12K212978Diode laser therapy systemBeijing Unt Technology Co., Ltd.20211—
+12K212793Laser Treatment System, Model: Hera, ArmoCanadian Pioneer Medical Technology Corporation20210—
+12K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+12K182741SculpSureCynosure20195—
+12K172771Epic Pro 940Biolase, Inc.20171—
+12K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+12K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+13K262524Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B…ONE BEAUTY Technology Co., Ltd.20260—
+13K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…Shenzhen Qianyu Technology Co., Ltd.20260—
+13K260307Diode Laser Therapy Systems (V19)Weifang Mingliang Electronics Co., Ltd.20260—
+13K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+13K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+13K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+13K252096Light Therapy Decollete Mask (1019135)Merchsource, LLC20250—
+13K251801Diode laser device (BM091)Hebei Newangie Technology Co., Ltd.20250—
+13K251707IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)Shenzhen Huachuangtong Industrial Co., Ltd.20250—
+13K250966CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+13K250431Medical Diode Laser Hair Removal System (MNLT-D1)Shandong Moonlight Electronics Tech Co., Ltd.20251—
+13K242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd20250—
+13K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+13K243465Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device…Guangzhou Chuang Zao Mei Technology Co., Ltd.20250—
+13K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+13K243737Inbella RF SystemInbella Medical, Inc.20250—
+13K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+13K241498Diode laser Treatment System (K18)Hebei Keylaser Sci-Tech Co.,Ltd20240—
+13K241120Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06…Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd.20241—
+13K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+13K230467BTL-899FBTL Industries, Inc.20231—
+13K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+13K223292TempSure SystemCynosure, LLC20220—
+13K214103Shani Darden LED light therapy maskHarpar Grace International202219—
+13K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+14K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.20260—
+14K252048808nm semiconductor laser hair removal machineXi'An Taibo Electronic Technology Co., Ltd.20260—
+14K252234IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16…Shenzhen Qiaochengli Technology Co., Ltd.20250—
+14K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V.202310—
+14K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+15K172144CoolSculpting SystemZeltiq Aesthetics20177—
+16K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805