510(k) Report

Devices descending from K014040

739 later devices reach Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K161185LUCERNA Dental LaserViax Dental Lab20160—
+6K160075Accent XLAlma Lasers, Inc.20160—
+6K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+6K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd.20160—
+6K152611V20 systemViora, Ltd.20164—
+6K150664NeoLasSheaumann Laser, Inc.20151—
+6K151655CO2RE SystemSyneron Medical, Ltd.20151—
+6K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+6K150035V10 systemViora, Ltd.201531—
+6K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+6K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+6K140732Candela Gentlelase Family of Laser SystemsCandela Corp.20141—
+6K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+6K140837Lucid LYBio-Med USA, Inc.20140—
+6K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+6K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+6K133364Picosure WorkstationCynosure, Inc.201451—
+6K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+6K130501IntensifEndymed Medical, Ltd.201457—
+6K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+6K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+6K131758Surgen UPollogen, Ltd.20135—
+6K131839DC 7Dc International, LLC20130—
+6K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+6K123573Youlaser CO2 LaserQuanta System Spa201319—
+6K130465EPIC 10SBiolase Technology, Inc.20130—
+6K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+6K121346Picosure WorkstationCynosure, Inc.201287—
+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—
+6K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+6K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+6K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+6K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+6K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+6K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+6K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+6K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+6K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+6K091115ECO2 Laser SystemLutronic Corporation200927—
+6K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+6K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+6K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+6K090525Loi SystemPalomar Medical Products, Inc.20099—
+6K080932Mosaic Laser SystemLutronic Corporation20086—
+6K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+6K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+7K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+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—
+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—
+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—
+7K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+7K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+7K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+7K250809Stellar M22Lumenis Be, 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—
+7K243488Vmat ProTermosalud20250—
+7K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+7K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+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—
+7K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+7K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+7K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+7K222790F65 Laser SystemLumenis Be, Ltd.20233—
+7K221865BTL-094BTL Industries, Inc.20230—
+7K210166Omnispec ED1000Medispec, Ltd.20230—
+7K222221Deka HelixEl.En Electronic Engineering Spa20231—
+7K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+7K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+7K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+7K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+7K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+7K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+7K212082PicoreBio-Med USA, Inc.20210—
+7K211444CellFX SystemPulse Biosciences, Inc.20213—
+7K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+7K202988Tixel SystemNovoxel, Ltd.20211—
+7K193266MIINMedico USA, Inc.20210—
+7K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+7K193201BTL-785FBtl20208—
+7K201406PicowonWontech Co., Ltd.20200—
+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—