510(k) Report

Devices descending from K963094

1,185 later devices reach Cynosure Photogenica LP Dermatological Vascular Lesion Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+7K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+7K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+7K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+7K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+7K063249BeamaxMedic Sharplight, Ltd.200758—
+7K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+7K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+7K052442Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd.200612—
+7K053324Chromolite SystemChromogenex Plc200631—
+7K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+7K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+7K041969Aurora DSSyneron Medical, Ltd.2004302—
+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—
+8K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.20260—
+8K253765Vanish ProDdc Technologies, Inc.20260—
+8K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.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—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K250165PastelleWontech Co., Ltd.20250—
+8K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+8K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+8K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+8K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+8K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+8K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+8K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+8K250809Stellar M22Lumenis Be, Ltd.20250—
+8K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+8K250281Deka LotusEl.En S.P.A.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—
+8K241270BTL-754BTL Industries, Inc.20251—
+8K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+8K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+8K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+8K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+8K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+8K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+8K241600DermablateAsclepion Laser Technologies GmbH20240—
+8K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+8K233344Regenalase Laser SystemIpg Medical20240—
+8K240752Deka ToroEl.En S.P.A.20240—
+8K233224Epilaser ProEpilady 2000, LLC20240—
+8K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+8K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+8K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+8K231394Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd.20232—
+8K230077LaserMENeauvia North America20232—
+8K222790F65 Laser SystemLumenis Be, Ltd.20233—
+8K222221Deka HelixEl.En Electronic Engineering Spa20231—
+8K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+8K221761SoleaConvergent Dental, Inc.202201
+8K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+8K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+8K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+8K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+8K213428EdgeProBiolase, Inc.20210—
+8K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+8K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+8K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+8K202955Contour Light CL-100Contour Research, LLC20218—
+8K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+8K203299CellFX SystemPulse Biosciences, Inc.20214—
+8K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+8K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+8K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+8K192275invisa-RED ELITEIR Technology, LLC20201—
+8K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+8K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+8K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+8K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+8K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+8K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+8K191086ExciplexClarteis20194—
+8K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20193—
+8K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+8K180359BTL-FR2000BTL Industries, Inc.20189—
+8K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+8K181868SHINY RPL SystemIds, Ltd.20181—
+8K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+8K180338CellulizeWard Photonics, LLC20182—
+8K181659Avologi ENEOPremier North America, Inc.20184—
+8K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+8K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+8K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+8K180320dpl IIa PanelLed Technologies, Inc.201814—
+8K180406Ellipse YdunEllipse A/S20180—
+8K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+8K172111Vevazz LEDVevazz, LLC20170—
+8K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—