510(k) Report

Devices descending from K981952

763 later devices reach Combination ND:Yag and Frequency Doubled Solid State Green Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+5K133837Viora V-TotalViora, Ltd.201433—
+5K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+5K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+5K130459Tria Fan SystemTria Beauty, Inc.20131—
+5K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+5K121346Picosure WorkstationCynosure, Inc.201287—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+5K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+5K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+5K112715Candela Gentlemax Family of LasersCandela Corp.201190—
+5K103455Spectra Laser SystemLutronic Corporation201192—
+5K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+5K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+5K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+5K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+5K092734E-Light LineEspansione Marketing S.P.A20102—
+5K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+5K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—
+5K093465Fusion SystemEclipsemed Global, Inc.20100—
+5K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+5K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+5K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+5K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+5K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+5K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+5K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp.2008112—
+5K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+5K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp.2008113—
+5K072344Apl Medical SystemBios S.R.L.20076—
+5K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+5K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+5K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+5K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+5K052354Oculase MDBiolase Technology, Inc.20065—
+5K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+5K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+5K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+5K050673Candela Family of Pulse Dye Laser SystemsCandela Corp.20051332
+5K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+6K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K253765Vanish ProDdc Technologies, Inc.20260—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K253342PICO-KSpeclipse, Inc.20251—
+6K253344Bellus-QSpeclipse, Inc.20250—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+6K241527Pastelle ProWontech Co., Ltd.20253—
+6K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+6K231948MediyagMedicreations, LLC20240—
+6K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+6K241656Eneka SelectifTermosalud20241—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+6K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+6K233344Regenalase Laser SystemIpg Medical20240—
+6K240752Deka ToroEl.En S.P.A.20240—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K234057NirvanaEl.En S.P.A.20240—
+6K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+6K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+6K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+6K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+6K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K231054V-LaserWontech Co., Ltd.20231—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—
+6K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+6K222701MANTA LaserSqualus Med, Ltd.20222—
+6K22079410PLTentech Co., Ltd.20220—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+6K203788DermaV Laser SystemLutronic Corporation202101
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K193266MIINMedico USA, Inc.20210—
+6K201406PicowonWontech Co., Ltd.20200—
+6K200616E>EyeCE-Swin20200—
+6K201111GentleMax Pro PlusCandela Corporation20203—
+6K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K200110SANDRO DualWontech Co., Ltd.20202—
+6K191942MT One DiamondM&T S.R.L.20191—