510(k) Report

Devices descending from K003202

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+5K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+5K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+5K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+5K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+6K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K253765Vanish ProDdc Technologies, Inc.20260—
+6K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+6K253342PICO-KSpeclipse, Inc.20251—
+6K251730LIA Console (542-7)Leadoptik, Inc.20250—
+6K252877SANDRO DualWontech Co., Ltd.20250—
+6K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+6K253344Bellus-QSpeclipse, Inc.20250—
+6K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K250165PastelleWontech Co., Ltd.20250—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K251094Alma VeilWontech Co., Ltd.20250—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+6K241527Pastelle ProWontech Co., Ltd.20253—
+6K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+6K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+6K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+6K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+6K231948MediyagMedicreations, LLC20240—
+6K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+6K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+6K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+6K240752Deka ToroEl.En S.P.A.20240—
+6K233143PiXel8-RevealRohrer Aesthetics20240—
+6K233224Epilaser ProEpilady 2000, LLC20240—
+6K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+6K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+6K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+6K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K22079410PLTentech Co., Ltd.20220—
+6K221761SoleaConvergent Dental, Inc.202201
+6K221427V-LaserWontech Co., Ltd.20222—
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K213428EdgeProBiolase, Inc.20210—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+6K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+6K203299CellFX SystemPulse Biosciences, Inc.20214—
+6K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+6K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+6K200616E>EyeCE-Swin20200—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+6K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+6K191086ExciplexClarteis20194—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+6K180359BTL-FR2000BTL Industries, Inc.20189—
+6K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+6K180406Ellipse YdunEllipse A/S20180—
+6K172413MT ONEM&T S.R.L.20175—
+6K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+6K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+6K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+6K163222Discovery Pico FamilyQuanta System Spa201630—
+6K160075Accent XLAlma Lasers, Inc.20160—
+6K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+6K153566Magma SystemFormatk Systems, Ltd.20162—
+6K152611V20 systemViora, Ltd.20164—
+6K150664NeoLasSheaumann Laser, Inc.20151—
+6K151655CO2RE SystemSyneron Medical, Ltd.20151—
+6K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+6K150035V10 systemViora, Ltd.201531—
+6K141868Tria FanpTria Beauty, Inc.20140—
+6K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+6K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+6K130501IntensifEndymed Medical, Ltd.201457—
+6K133283Candela Gentlemax Family of Laser SystemsCandela Corp.201313—
+6K131758Surgen UPollogen, Ltd.20135—
+6K132185Family of Coolglide Aesthetic LasersCutera, Inc.201336—
+6K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+6K130199Clarity LPC Laser SystemLutronic Corporation20135—
+6K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+6K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+6K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+6K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+6K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+6K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—