510(k) Report

Devices descending from K042000

517 later devices reach Modified MSQ Family of Lovely Light/Laser Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+3K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+3K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+3K081352Profile Multi-Platform SystemSciton, Inc2008112—
+3K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+3K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+3K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+3K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+4K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+4K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+4K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+4K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+4K250165PastelleWontech Co., Ltd.20250—
+4K251632Optimas MAX SystemInMode, Ltd.20251—
+4K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+4K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+4K250189AdvaTxAdvalight Aps20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+4K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+4K233473Deka LotusEl.En S.P.A.20241—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K210847UltraClear Fractional Laser SystemFa International, LP20210—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K212607DarwinLuvo Medical Technologies, Inc.20210—
+4K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+4K211444CellFX SystemPulse Biosciences, Inc.20213—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K202988Tixel SystemNovoxel, Ltd.20211—
+4K193201BTL-785FBtl20208—
+4K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+4K191065Venus VivaTMVenus Concept USA, Inc.20200—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K191942MT One DiamondM&T S.R.L.20191—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+4K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+4K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+4K160312Fraxis DuoIlooda Co,., Ltd.201614—
+4K153717Venus Versa SystemVenus Concept, Ltd.20161—
+4K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K142093V20 SystemViora, Ltd.201432—
+4K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+4K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+4K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+4K133364Picosure WorkstationCynosure, Inc.201451—
+4K133774AtovenBio-Med USA, Inc.20146—
+4K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+4K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+4K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+4K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+4K121346Picosure WorkstationCynosure, Inc.201287—
+4K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+4K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+4K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+4K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+4K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+4K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+4K100558Quanta Diode Laser SystemQuanta System Spa201068—
+4K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+4K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+5K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K261964Echolaser X4Elesta S.P.A20260—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+5K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K250281Deka LotusEl.En S.P.A.20250—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K241270BTL-754BTL Industries, Inc.20251—
+5K243139Reverso Pro SystemIndiba S. A. U.20250—
+5K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+5K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+5K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+5K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+5K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+5K233344Regenalase Laser SystemIpg Medical20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+5K230077LaserMENeauvia North America20232—
+5K223033Tixel® 2 SystemNovoxel, Ltd.20230—