510(k) Report

Devices descending from K022226

665 later devices reach Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+6K131839DC 7Dc International, LLC20130—
+6K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+6K130465EPIC 10SBiolase Technology, Inc.20130—
+6K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+6K121346Picosure WorkstationCynosure, Inc.201287—
+6K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+6K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+6K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+6K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+6K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+6K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+6K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+6K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+7K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+7K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+7K251730LIA Console (542-7)Leadoptik, Inc.20250—
+7K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+7K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+7K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+7K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+7K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+7K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+7K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+7K250281Deka LotusEl.En S.P.A.20250—
+7K243488Vmat ProTermosalud20250—
+7K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+7K241270BTL-754BTL Industries, Inc.20251—
+7K243139Reverso Pro SystemIndiba S. A. U.20250—
+7K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+7K230077LaserMENeauvia North America20232—
+7K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+7K221865BTL-094BTL Industries, Inc.20230—
+7K210166Omnispec ED1000Medispec, Ltd.20230—
+7K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+7K213674CellFX SystemPulse Biosciences, Inc.20220—
+7K222075CellFX SystemPulse Biosciences, Inc.20220—
+7K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+7K221671CellFX® SystemPulse Biosciences, Inc.20220—
+7K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+7K211639BTL-785WBTL Industries, Inc.20227—
+7K212107ReversoIntelis Instruments, Ltd.20211—
+7K212082PicoreBio-Med USA, Inc.20210—
+7K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+7K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+7K193266MIINMedico USA, Inc.20210—
+7K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+7K201406PicowonWontech Co., Ltd.20200—
+7K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K193426Elite iQCynosure, LLC20201—
+7K192545PotenzaJeisys Medical Incorporated202020—
+7K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+7K191855EmFace DeviceInmode MD, Ltd.20191—
+7K181095RF-ReliefEl Global Trade, Ltd.20181—
+7K173700PICOPLUS Laser SystemLutronic Corporation20187—
+7K173503Pollogen Legend SystemPollogen, Ltd.20183—
+7K173199PicoSure WorkstationCynosure, Inc.20189—
+7K172302InMode PLUS SystemInmode MD, Ltd.201713—
+7K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+7K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+7K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+7K172096FraxisIlooda Co,., Ltd.20172—
+7K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+7K170325Secret RFIlooda Co,., Ltd.201710—
+7K162755PicocareWontech Co., Ltd.20179—
+7K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+7K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+7K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+7K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+7K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+7K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+7K152856Helios IIILaseroptek Co., Ltd.20165—
+7K160480PicoSure WorkstationCynosure, Inc.201620—
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+7K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+7K150326PicoWay Laser SystemCandela Corporation201568—
+7K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+7K143105Picosure WorkstationCynosure, Inc.201549—
+7K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+7K142860Lumenis M22 SystemLumenis, Ltd.2015381
+7K142372Pico Way Laser SystemCandela Corpation201470—
+7K140719Picosure WorkstationCynosure, Inc.201450—
+7K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+7K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+7K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+8K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+8K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+8K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+8K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+8K253123CuRAS hybridClassys, Inc.20250—
+8K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+8K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+8K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—