510(k) Report

Devices descending from K981351

811 later devices reach Candela Gentlelase GL Dermatological Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K222790F65 Laser SystemLumenis Be, Ltd.20233—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K222221Deka HelixEl.En Electronic Engineering Spa20231—
+7K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K221761SoleaConvergent Dental, Inc.202201
+7K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+7K213428EdgeProBiolase, Inc.20210—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+7K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+7K203299CellFX SystemPulse Biosciences, Inc.20214—
+7K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+7K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+7K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+7K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+7K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+7K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+7K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+7K191086ExciplexClarteis20194—
+7K191942MT One DiamondM&T S.R.L.20191—
+7K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+7K180359BTL-FR2000BTL Industries, Inc.20189—
+7K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+7K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+7K180406Ellipse YdunEllipse A/S20180—
+7K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+7K172413MT ONEM&T S.R.L.20175—
+7K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+7K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+7K163222Discovery Pico FamilyQuanta System Spa201630—
+7K161185LUCERNA Dental LaserViax Dental Lab20160—
+7K160075Accent XLAlma Lasers, Inc.20160—
+7K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+7K152611V20 systemViora, Ltd.20164—
+7K150664NeoLasSheaumann Laser, Inc.20151—
+7K151655CO2RE SystemSyneron Medical, Ltd.20151—
+7K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+7K150035V10 systemViora, Ltd.201531—
+7K141868Tria FanpTria Beauty, Inc.20140—
+7K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+7K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+7K130501IntensifEndymed Medical, Ltd.201457—
+7K131758Surgen UPollogen, Ltd.20135—
+7K131839DC 7Dc International, LLC20130—
+7K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+7K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+7K130465EPIC 10SBiolase Technology, Inc.20130—
+7K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+7K120513Glow by EndymedEndymed Medical, Ltd.20125—
+7K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+7K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+7K113588Spectra Laser SystemLutronic Corporation201282—
+7K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+7K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+7K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+7K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+7K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+7K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+7K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+7K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+7K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+7K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+7K090094Zeltiq SystemZeltiq Aesthetics200932—
+7K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+7K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+7K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+7K070392Mosaic Laser SystemLutronic Corporation20078—
+7K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+7K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+7K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+8K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+8K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+8K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+8K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+8K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+8K251730LIA Console (542-7)Leadoptik, Inc.20250—
+8K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+8K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+8K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+8K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+8K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+8K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+8K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+8K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+8K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+8K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K242349FoLixLumenis Be, Ltd.20240—
+8K233473Deka LotusEl.En S.P.A.20241—
+8K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K233143PiXel8-RevealRohrer Aesthetics20240—