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
+7K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+7K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+7K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+7K091115ECO2 Laser SystemLutronic Corporation200927—
+7K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+7K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+7K090525Loi SystemPalomar Medical Products, Inc.20099—
+7K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+7K080932Mosaic Laser SystemLutronic Corporation20086—
+7K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+7K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+8K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+8K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+8K261570Picosure WorkstationCynosure, LLC20260—
+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—
+8K260974CO2 Laser Machine (Monica-I,Monica-II)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—
+8K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+8K252369Boston Pico755Boston Aesthetics, Inc.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—
+8K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+8K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+8K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+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—
+8K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+8K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+8K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+8K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+8K250809Stellar M22Lumenis Be, 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—
+8K243957PicoalexWontech Co., Ltd.20250—
+8K243488Vmat ProTermosalud20250—
+8K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+8K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+8K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+8K233473Deka LotusEl.En S.P.A.20241—
+8K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+8K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+8K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+8K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+8K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+8K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+8K222790F65 Laser SystemLumenis Be, Ltd.20233—
+8K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+8K221865BTL-094BTL Industries, Inc.20230—
+8K210166Omnispec ED1000Medispec, Ltd.20230—
+8K222221Deka HelixEl.En Electronic Engineering Spa20231—
+8K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+8K220853PicoWay Laser SystemCandela Corporation20221—
+8K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+8K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+8K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+8K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+8K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+8K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+8K212127PicocaremajestyWontech Co., Ltd.20226—
+8K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+8K201773PicohiHironic Co., Ltd.20215—
+8K212082PicoreBio-Med USA, Inc.20210—
+8K211444CellFX SystemPulse Biosciences, Inc.20213—
+8K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+8K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+8K202988Tixel SystemNovoxel, Ltd.20211—
+8K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+8K202041Opera EvoQuanta System Spa20200—
+8K193201BTL-785FBtl20208—
+8K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+8K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+8K191065Venus VivaTMVenus Concept USA, Inc.20200—
+8K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+8K193426Elite iQCynosure, LLC20201—
+8K192331LaseMD LEO Laser SystemLutronic Global20190—
+8K182173Joule SystemSciton, Inc20195—
+8K182669Youlaser CO2Quanta System Spa20181—
+8K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+8K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+8K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+8K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+8K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+8K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+8K170637sensiFirmEl Global Trade, Ltd.20173—
+8K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+8K171009LASEMD Laser SystemLutronic Corporation20178—
+8K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+8K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+8K160312Fraxis DuoIlooda Co,., Ltd.201614—
+8K161043Profound SystemSyneron Candela Corporation20160—
+8K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+8K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+8K153568InMode Plus SystemInmode MD, Ltd.201618—
+8K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+8K153717Venus Versa SystemVenus Concept, Ltd.20161—
+8K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—