510(k) Report

Devices descending from K014035

668 later devices reach Cooltouch and Cooltouch-II ND:Yag Laser Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K213594Echolaser X4Elesta S.P.A20221—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K213428EdgeProBiolase, Inc.20210—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K211444CellFX SystemPulse Biosciences, Inc.20213—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K202988Tixel SystemNovoxel, Ltd.20211—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K193201BTL-785FBtl20208—
+6K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K191065Venus VivaTMVenus Concept USA, Inc.20200—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+6K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+6K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+6K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+6K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+6K180406Ellipse YdunEllipse A/S20180—
+6K171702Exciplex308nmClarteis20175—
+6K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K160368EVO platformQuanta System Spa201636—
+6K153717Venus Versa SystemVenus Concept, Ltd.20161—
+6K152611V20 systemViora, Ltd.20164—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K150664NeoLasSheaumann Laser, Inc.20151—
+6K150035V10 systemViora, Ltd.201531—
+6K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+6K140120EPIC 10Biolase, Inc.20141—
+6K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+6K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+6K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+6K133364Picosure WorkstationCynosure, Inc.201451—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+6K124064Young AgainEspansione Marketing S.P.A20131—
+6K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+6K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—
+6K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+6K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+6K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K121346Picosure WorkstationCynosure, Inc.201287—
+6K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+6K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+6K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+6K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+6K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+6K113588Spectra Laser SystemLutronic Corporation201282—
+6K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+6K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+6K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+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—
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+7K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+7K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+7K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+7K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+7K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+7K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+7K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+7K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+7K250281Deka LotusEl.En S.P.A.20250—
+7K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+7K241270BTL-754BTL Industries, Inc.20251—
+7K243139Reverso Pro SystemIndiba S. A. U.20250—
+7K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+7K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+7K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+7K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K233143PiXel8-RevealRohrer Aesthetics20240—
+7K233224Epilaser ProEpilady 2000, LLC20240—
+7K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+7K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K230077LaserMENeauvia North America20232—
+7K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—