510(k) Report

Devices descending from K020839

1,046 later devices reach Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K190743Venus BlissVenus Concept USA, Inc.20194—
+10K172771Epic Pro 940Biolase, Inc.20171—
+10K171111SculpsureCynosure, Inc.201710—
+10K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+10K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+11K254185Potenza PrimeJeisys Medical Incorporated20260—
+11K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+11K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+11K253803MILAN SystemLumenis Be, Ltd.20260—
+11K260138LUNE PureHygieneEnamel Pure20260—
+11K253750BTL-785NEHBTL Industries, Inc.20260—
+11K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+11K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+11K251254Ignite RF SystemInMode, Ltd.20260—
+11K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+11K253007Laser 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—
+11K252367InbellaMulti SystemInbella Medical, Inc.20250—
+11K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+11K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+11K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+11K242532BTL-785BNF-EBTL Industries, Inc.20241—
+11K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+11K233642InMode RF SystemInMode, Ltd.20244—
+11K222226EONDominion Aesthetic Technologies, Inc.20230—
+11K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+11K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+11K212331BodySculpRohrer Aesthetics, LLC20211—
+11K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+11K192970SlimusHironic Co., Ltd.20200—
+11K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+11K171992SculpSureCynosure, Inc.20178—
+11K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+12K261701Hemolase 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—
+12K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+12K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+12K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+12K240780InMode RF SystemInMode, Ltd.20243—
+12K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+12K231971Deka Physiq 360El.En S.P.A.20230—
+12K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+12K182741SculpSureCynosure20195—
+12K172144CoolSculpting SystemZeltiq Aesthetics20177—
+13K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+13K243737Inbella RF SystemInbella Medical, Inc.20250—
+13K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+13K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805