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
+6K120513Glow by EndymedEndymed Medical, Ltd.20125—
+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—
+6K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+6K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+6K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+6K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+6K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+6K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+6K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+6K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+6K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+6K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+6K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+6K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+6K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+6K070392Mosaic Laser SystemLutronic Corporation20078—
+6K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+6K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+6K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+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—
+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—
+7K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+7K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+7K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+7K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+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—
+7K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+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—
+7K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+7K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+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—
+7K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K233473Deka LotusEl.En S.P.A.20241—
+7K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+7K211444CellFX SystemPulse Biosciences, Inc.20213—
+7K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+7K202988Tixel SystemNovoxel, Ltd.20211—
+7K193201BTL-785FBtl20208—
+7K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+7K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+7K191065Venus VivaTMVenus Concept USA, Inc.20200—
+7K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+7K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+7K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+7K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+7K183566CLARITY II Laser SystemLutronic Corporation201911
+7K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+7K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemFinemec Co., Ltd.20180—
+7K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+7K173700PICOPLUS Laser SystemLutronic Corporation20187—
+7K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+7K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+7K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+7K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+7K171648BM.IrisBluecore Co., Ltd.20172—
+7K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+7K170637sensiFirmEl Global Trade, Ltd.20173—
+7K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+7K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+7K162781Magma SparkFormatk Systems, Ltd.20160—
+7K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+7K160312Fraxis DuoIlooda Co,., Ltd.201614—
+7K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+7K161043Profound SystemSyneron Candela Corporation20160—
+7K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+7K153568InMode Plus SystemInmode MD, Ltd.201618—
+7K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd.20160—
+7K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+7K153717Venus Versa SystemVenus Concept, Ltd.20161—
+7K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+7K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+7K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+7K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+7K140732Candela Gentlelase Family of Laser SystemsCandela Corp.20141—
+7K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+7K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+7K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+7K140837Lucid LYBio-Med USA, Inc.20140—
+7K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+7K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+7K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+7K133364Picosure WorkstationCynosure, Inc.201451—
+7K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+7K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+7K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+7K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351