510(k) Report

Devices descending from K980517

1,509 later devices reach Epilaser Normal Mode Ruby Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K103455Spectra Laser SystemLutronic Corporation201192—
+5K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+5K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+5K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+5K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+5K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+5K103415Tanda MaxPharos Life Corporation20110—
+5K100628PlasmaluxlsDaavlin Distributing Co.20100—
+5K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+5K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+5K101321Ematrix CO2Syneron Medical, Ltd.20102—
+5K102716Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc.2010124—
+5K091467Baby QuasarSilver Bay, LLC20100—
+5K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+5K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+5K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+5K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+5K093168Mediflash and EsteflashDermeo20100—
+5K090744CLAROClrs Technology Corporation20101—
+5K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+5K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+5K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+5K090312Tria Acne Treatment System, Model Ats-1 OtcTria Beauty, Inc.20101—
+5K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+5K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd.20094—
+5K091534Lightlas Model 532Lightmed Corp.200972—
+5K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+5K090221Reaction SystemViora, Ltd.200954—
+5K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+5K090525Loi SystemPalomar Medical Products, Inc.20099—
+5K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+5K083595EzlaseBiolase Technology, Inc.200958—
+5K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+5K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+5K083730IsolazAesthera Corporation20093—
+5K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+5K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+5K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+5K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+5K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+5K080374Biosyag Medical SystemBios S.R.L.20082—
+5K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.2008101—
+5K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+5K072925Candela-Inolase Serenity Pro PSF SystemInolase, Ltd.20080—
+5K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+5K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+5K071872VelashapeSyneron Medical, Ltd.2007127—
+5K071469Inolase Serenity PSF ( Pneumatic Skin Flattening) SystemCandela Corp.20071—
+5K071943Serenity Pro PSF SystemInolase 2002, Ltd.20071—
+5K070092Modification to Velasmooth, ShaperSyneron Medical, Ltd.2007128—
+5K070392Mosaic Laser SystemLutronic Corporation20078—
+5K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+5K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+5K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+5K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+5K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+5K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+5K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+5K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+5K061603SmoothshapesBiocellulase, Inc.200648—
+5K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+5K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+5K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+5K053611SmoothshapesBicellulase, Inc.200695—
+5K052442Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd.200612—
+5K052324Polaris LV, Lva ApplicatorSyneron Medical, Ltd.2005456—
+5K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+5K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+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—
+6K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K253765Vanish ProDdc Technologies, Inc.20260—
+6K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+6K260632Laser Thermal Therapy KitElesta S.P.A20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+6K253342PICO-KSpeclipse, Inc.20251—
+6K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+6K253344Bellus-QSpeclipse, Inc.20250—
+6K253035IPL Hair Removal Device (SYL001AZ, SYL002AZ)Gu'An Yeolight Smart Electronics Co., Ltd.20250—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+6K250165PastelleWontech Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+6K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+6K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+6K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K250281Deka LotusEl.En S.P.A.20250—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+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—
+6K243488Vmat ProTermosalud20250—
+6K241270BTL-754BTL Industries, Inc.20251—
+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—
+6K242710Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro…Shenzhen Jianchao Intelligent Technology Co., Ltd.20243—