510(k) Report

Devices descending from K962109

1,499 later devices reach SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser System for Hair… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K191629faceLITEIsmart Marketing Svcs, Ltd.201971—
+10K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+10K183671LG Pra.L Derma Led MaskLg Electronics.Inc201948—
+10K171992SculpSureCynosure, Inc.20178—
+10K170709CURVE Laser SystemYolo Medical, Inc.20170—
+10K163197Cook Holmium Laser FiberCook Incorporated20170—
+10K163128Epic ProBiolase, Inc.201716—
+10K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+10K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+10K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+10K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+10K134040BTL-9000; BTL-9000 Radiofrequency ModuleBtl Industries, Ltd.20140—
+10K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+10K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+11K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+11K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.20260—
+11K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+11K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.20260—
+11K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…Dongguan Miqiang Technology Co., Ltd.20260—
+11K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.20260—
+11K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.20260—
+11K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+11K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+11K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+11K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.20250—
+11K252308LED Beauty Mask (RLBXX)Atop Lighting Co., Ltd.20250—
+11K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd.20252—
+11K252093Light Therapy Mask (1019055)Merchsource, LLC20250—
+11K251457Diode laser therapy device (VADER)Beijing Superlaser Technology Co., Ltd.20250—
+11K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+11K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+11K250581KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+11K250131IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011…Mustech Electronics Co., Limited20250—
+11K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+11K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+11K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+11K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+11K242382décoLITE LED DeviceiSMART Developments, Ltd.20246—
+11K242595Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)Shenzhen Greatro Electronic Technology Co., Ltd.20243—
+11K240780InMode RF SystemInMode, Ltd.20243—
+11K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+11K232709Diode laser therapy deviceHebei Zhemai Technology Co., Ltd.20231—
+11K232575Hair Removal Device, Model (s): R2815-G Pro, R2815-GShenzhen Jianchao Intelligent Technology Co., Ltd.20235—
+11K231901Hakon, Hakon SmartMedical San Indústria DE Equipamentos Médicos Ltda.20230—
+11K231971Deka Physiq 360El.En S.P.A.20230—
+11K231613Intense pulsed light device, Model (s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B…Zhuzhou Goldenhot Medical Technology Co., Ltd.20238—
+11K230351LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd.202333—
+11K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+11K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V.20227—
+11K221946LED Light Therapy Mask (model: MK66R-B)Light Tree Ventures Europe B.V.202218—
+11K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.202241—
+11K221312Diode Laser Hair Removal DeviceGuangzhou Chuang Zao Mei Technology Co., Ltd.20224—
+11K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+11K212891TempSure SystemCynosure, LLC20221—
+11K213344BTL-899ABTL Industries, Inc.20222—
+11K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin202135—
+11K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+11K212978Diode laser therapy systemBeijing Unt Technology Co., Ltd.20211—
+11K212793Laser Treatment System, Model: Hera, ArmoCanadian Pioneer Medical Technology Corporation20210—
+11K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+11K202503ChromeQuanta System Spa202012—
+11K182741SculpSureCynosure20195—
+11K172771Epic Pro 940Biolase, Inc.20171—
+11K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+11K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+12K262524Sapphire 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—
+12K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…Shenzhen Qianyu Technology Co., Ltd.20260—
+12K260307Diode Laser Therapy Systems (V19)Weifang Mingliang Electronics Co., Ltd.20260—
+12K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+12K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+12K253007Laser 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—
+12K252096Light Therapy Decollete Mask (1019135)Merchsource, LLC20250—
+12K251801Diode laser device (BM091)Hebei Newangie Technology Co., Ltd.20250—
+12K251707IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)Shenzhen Huachuangtong Industrial Co., Ltd.20250—
+12K250966CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+12K250431Medical Diode Laser Hair Removal System (MNLT-D1)Shandong Moonlight Electronics Tech Co., Ltd.20251—
+12K242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd20250—
+12K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+12K243465Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device…Guangzhou Chuang Zao Mei Technology Co., Ltd.20250—
+12K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+12K243737Inbella RF SystemInbella Medical, Inc.20250—
+12K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+12K241498Diode laser Treatment System (K18)Hebei Keylaser Sci-Tech Co.,Ltd20240—
+12K241120Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06…Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd.20241—
+12K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+12K230467BTL-899FBTL Industries, Inc.20231—
+12K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+12K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+12K223292TempSure SystemCynosure, LLC20220—
+12K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+12K214103Shani Darden LED light therapy maskHarpar Grace International202219—
+12K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+13K261701Hemolase 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—
+13K252048808nm semiconductor laser hair removal machineXi'An Taibo Electronic Technology Co., Ltd.20260—
+13K252234IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16…Shenzhen Qiaochengli Technology Co., Ltd.20250—
+13K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V.202310—
+13K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+14K172144CoolSculpting SystemZeltiq Aesthetics20177—
+15K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805