510(k) Report

Devices descending from K971874

816 later devices reach Sharplan Epitouch Alexandrite Laser System (5000) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K213294Dermal Cooling SystemR2 Technologies, Inc.20221—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K213594Echolaser X4Elesta S.P.A20221—
+7K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+7K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+7K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+7K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+7K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K202172StarWalkerFotona D.O.O.20203—
+7K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+7K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+7K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+7K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+7K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+7K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+7K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+7K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+7K171702Exciplex308nmClarteis20175—
+7K163196ACTION II Laser SystemLutronic Corporation20170—
+7K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+7K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+7K162781Magma SparkFormatk Systems, Ltd.20160—
+7K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+7K161669Waterlase ExpressBiolase, Inc.201621—
+7K152737Lite TouchFocus Medical, LLC20160—
+7K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+7K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+7K153229SuperbiumBios S.R.L.20162—
+7K160368EVO platformQuanta System Spa201636—
+7K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+7K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+7K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+7K151306SoleaConvergent Dental, Inc.20151—
+7K142093V20 SystemViora, Ltd.201432—
+7K140120EPIC 10Biolase, Inc.20141—
+7K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+7K133774AtovenBio-Med USA, Inc.20146—
+7K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+7K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+7K124064Young AgainEspansione Marketing S.P.A20131—
+7K130459Tria Fan SystemTria Beauty, Inc.20131—
+7K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—
+7K130420SOLEAConvergent Dental, Inc.201321
+7K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+7K122200A3F FrationalPollogen, Ltd.20130—
+7K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+7K121327Diolase 10SBiolase Technology, Inc.20132—
+7K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+7K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+7K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+7K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+7K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+7K102461FractoraInvasix, Ltd.201124—
+7K103455Spectra Laser SystemLutronic Corporation201192—
+7K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+7K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+7K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+7K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+7K101321Ematrix CO2Syneron Medical, Ltd.20102—
+7K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+7K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+7K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+7K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+7K093465Fusion SystemEclipsemed Global, Inc.20100—
+7K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+7K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+7K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+7K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+7K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+7K080374Biosyag Medical SystemBios S.R.L.20082—
+7K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+7K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+7K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+7K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+7K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+7K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+7K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+8K252723Dynamis Pro FamilyFotona D.O.O.20260—
+8K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+8K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K253765Vanish ProDdc Technologies, Inc.20260—
+8K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+8K253342PICO-KSpeclipse, Inc.20251—
+8K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+8K253344Bellus-QSpeclipse, Inc.20250—
+8K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+8K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+8K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+8K250165PastelleWontech Co., Ltd.20250—
+8K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+8K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+8K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+8K250809Stellar M22Lumenis Be, Ltd.20250—
+8K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+8K241527Pastelle ProWontech Co., Ltd.20253—
+8K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+8K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—