510(k) Report

Devices descending from K003715

763 later devices reach Cooltouch ND:Yag Laser System, Cooltouch-II ND:Yag Laser System, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+6K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+6K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+6K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+6K191086ExciplexClarteis20194—
+6K192331LaseMD LEO Laser SystemLutronic Global20190—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+6K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+6K183566CLARITY II Laser SystemLutronic Corporation201911
+6K182173Joule SystemSciton, Inc20195—
+6K180359BTL-FR2000BTL Industries, Inc.20189—
+6K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+6K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemFinemec Co., Ltd.20180—
+6K182669Youlaser CO2Quanta System Spa20181—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+6K180406Ellipse YdunEllipse A/S20180—
+6K171648BM.IrisBluecore Co., Ltd.20172—
+6K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+6K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+6K171009LASEMD Laser SystemLutronic Corporation20178—
+6K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+6K163222Discovery Pico FamilyQuanta System Spa201630—
+6K162781Magma SparkFormatk Systems, Ltd.20160—
+6K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K161503ORIONYerim Engineering Co., Ltd.20161—
+6K160075Accent XLAlma Lasers, Inc.20160—
+6K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd.20160—
+6K152611V20 systemViora, Ltd.20164—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+6K150664NeoLasSheaumann Laser, Inc.20151—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+6K150035V10 systemViora, Ltd.201531—
+6K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+6K150027CYMAWhitecap Technologies, LLC20150—
+6K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+6K140732Candela Gentlelase Family of Laser SystemsCandela Corp.20141—
+6K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+6K140120EPIC 10Biolase, Inc.20141—
+6K140837Lucid LYBio-Med USA, Inc.20140—
+6K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+6K133364Picosure WorkstationCynosure, Inc.201451—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+6K133774AtovenBio-Med USA, Inc.20146—
+6K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K130501IntensifEndymed Medical, Ltd.201457—
+6K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+6K131758Surgen UPollogen, Ltd.20135—
+6K132754Neogen PSR SystemEnergist, Ltd.20132—
+6K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—
+6K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+6K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+6K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+6K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+6K121346Picosure WorkstationCynosure, Inc.201287—
+6K120513Glow by EndymedEndymed Medical, Ltd.20125—
+6K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+6K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+6K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+6K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+6K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+6K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+6K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+6K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+6K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+6K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+6K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+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—
+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—
+7K244060eCO2 3DLutronic Corporation20250—
+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—
+7K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+7K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+7K250809Stellar M22Lumenis Be, Ltd.20250—
+7K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.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—
+7K243488Vmat ProTermosalud20250—
+7K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—