510(k) Report

Devices descending from K971737

1,000 later devices reach Cynosure Photogenica Lpir Dermatological Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+11K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+11K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+11K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+11K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+11K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+11K242688Finiff SystemSkingrab Co., Ltd.20240—
+11K231216PotenzaJeisys Medical, Inc.20244—
+11K231287PotenzaJeisys Medical, Inc.20241—
+11K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K241406LavieenWontech Co., Ltd.20242—
+11K233123SilkroHironic Co., Ltd.20241—
+11K240969IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)Shenzhen Semlamp Intelligent Technology Co., Ltd.20240—
+11K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+11K233099GladiatorRohrer Aesthetics, LLC20240—
+11K240999Legend X Applicator VOPollogen, Ltd.20241—
+11K233849BTL-499BTL Industries, Inc.20240—
+11K233604BTL-785SBTL Industries, Inc.20243—
+11K240264Home Use Hair Removal Device (Model (s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A…Shenzhen Mlay Intelligent Technology Co.,, Ltd.20246—
+11K230837PlazMagikAgnes Medical Co., Ltd.20240—
+11K232846Light Based Hair Removal DeviceShenzhen Meik Beauty Industry Co., Ltd.20230—
+11K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+11K232932Intense Pulse Light Therapeutic ApparatusShenzhen Greatro Electronic Technology Co., Ltd.20235—
+11K232845IPL Cooling Hair Removal DeviceShenzhen Siken 3D Technology Development Co., Ltd.20230—
+11K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+11K233147PiXel8-RFRohrer Aesthetics20230—
+11K232223PlaDuo SystemShenB Co., Ltd.20230—
+11K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+11K230549IPL Hair Removal Device, Model (s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG…Shenzhen Xiazhifeng Electronic Co., Ltd.20230—
+11K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+11K223928Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E…Shenzhen Fansizhe Science and Technology Co., Ltd.202312—
+11K212472AgeJetTriworks Group Srl20220—
+11K211000AcutronIlooda Co,., Ltd.20220—
+11K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+11K211681EONDominion Aesthetic Technologies, Inc.20221—
+11K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+11K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+11K202503ChromeQuanta System Spa202012—
+11K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+11K190743Venus BlissVenus Concept USA, Inc.20194—
+11K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+11K171111SculpsureCynosure, Inc.201710—
+11K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+11K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+12K254185Potenza PrimeJeisys Medical Incorporated20260—
+12K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+12K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+12K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+12K253803MILAN SystemLumenis Be, Ltd.20260—
+12K253750BTL-785NEHBTL Industries, Inc.20260—
+12K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+12K251254Ignite RF SystemInMode, Ltd.20260—
+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—
+12K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+12K252367InbellaMulti SystemInbella Medical, Inc.20250—
+12K251334New Doublo 2.0Hironic Co., Ltd.20250—
+12K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+12K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+12K250131IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011…Mustech Electronics Co., Limited20250—
+12K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+12K242532BTL-785BNF-EBTL Industries, Inc.20241—
+12K242595Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)Shenzhen Greatro Electronic Technology Co., Ltd.20243—
+12K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+12K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+12K233642InMode RF SystemInMode, Ltd.20244—
+12K232575Hair Removal Device, Model (s): R2815-G Pro, R2815-GShenzhen Jianchao Intelligent Technology Co., Ltd.20235—
+12K230167BACK 4Swims America Corp20230—
+12K231613Intense pulsed light device, Model (s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B…Zhuzhou Goldenhot Medical Technology Co., Ltd.20238—
+12K230037BACK 3Swims America Corp20230—
+12K222226EONDominion Aesthetic Technologies, Inc.20230—
+12K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+12K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+12K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+12K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+12K212331BodySculpRohrer Aesthetics, LLC20211—
+12K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+12K192970SlimusHironic Co., Ltd.20200—
+12K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+12K171992SculpSureCynosure, Inc.20178—
+12K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+13K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+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—
+13K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+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—
+13K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+13K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+13K251707IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)Shenzhen Huachuangtong Industrial Co., Ltd.20250—
+13K240780InMode RF SystemInMode, Ltd.20243—
+13K241120Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06…Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd.20241—
+13K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+13K231971Deka Physiq 360El.En S.P.A.20230—
+13K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+13K182741SculpSureCynosure20195—
+13K172144CoolSculpting SystemZeltiq Aesthetics20177—
+14K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+14K252234IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16…Shenzhen Qiaochengli Technology Co., Ltd.20250—
+14K243737Inbella RF SystemInbella Medical, Inc.20250—
+14K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+14K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805