510(k) Report

Devices descending from K002072

1,118 later devices reach Prolite VL Pulsed Light System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+7K220385Intense Pulsed Light EquipmentBeijing Globalipl Development Co., Ltd.20220—
+7K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+7K221671CellFX® SystemPulse Biosciences, Inc.20220—
+7K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+7K221083Smartlux MiniMedmix Co., Ltd.20222—
+7K212663Helios IV 785Laseroptek Co., Ltd.20223—
+7K210084SilkroHironic Co., Ltd.20223—
+7K213261EpilMENeauvia North America20220—
+7K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+7K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+7K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+7K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+7K212107ReversoIntelis Instruments, Ltd.20211—
+7K212082PicoreBio-Med USA, Inc.20210—
+7K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+7K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+7K210226PicoSure WorkstationCynosure, LLC20213—
+7K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+7K201685PotenzaJeisys Medical, Inc.20219—
+7K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+7K201735PlaDuo SystemShenB Co., Ltd.20203—
+7K200693K2 MobileHulaser, Inc.20202—
+7K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+7K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+7K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+7K201111GentleMax Pro PlusCandela Corporation20203—
+7K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+7K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+7K200110SANDRO DualWontech Co., Ltd.20202—
+7K193486Epic 980Biolase, Inc.20202—
+7K193426Elite iQCynosure, LLC20201—
+7K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+7K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd.20191—
+7K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd.20191—
+7K192224BTL-899Btl20198—
+7K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd.20192—
+7K191685PicoWay Laser SystemCandela Corporation201920—
+7K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+7K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+7K183452Vbeam Prima Laser SystemCandela Corp.20191—
+7K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+7K182997enlighten III Laser SystemCutera, Inc.20180—
+7K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+7K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+7K180875Poly RejuvMedtek Skincare, LLC20180—
+7K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+7K181272Picocare FamilyWontech Co., Ltd.20188—
+7K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+7K173700PICOPLUS Laser SystemLutronic Corporation20187—
+7K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+7K1718212 Face / Face EvolutionHeat IN A Click201858—
+7K180406Ellipse YdunEllipse A/S20180—
+7K180224Element-TLElemenic Co., Ltd.20180—
+7K180044SIROLaser BlueDentsply Sirona201812—
+7K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+7K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+7K171262TempSureCynosure, Inc.201716—
+7K172004truSculptCutera, Inc.20173—
+7K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+7K170637sensiFirmEl Global Trade, Ltd.20173—
+7K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+7K162659Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd.201740—
+7K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+7K170068Softcure 96Wellray Medical Laser, Inc.20170—
+7K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+7K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+7K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+7K161692Diode Laser Therapy MachineBeijing Adss Development Co., Ltd.20166—
+7K161981Olive PlusAma Network, Inc.20160—
+7K161185LUCERNA Dental LaserViax Dental Lab20160—
+7K161043Profound SystemSyneron Candela Corporation20160—
+7K161661Thermi RF AccessoriesThermi20163—
+7K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+7K160470SculpSureCynosure, Inc.201620—
+7K152731XP1100 RFBTL Industries, Inc.20160—
+7K153568InMode Plus SystemInmode MD, Ltd.201618—
+7K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+7K151793InMode RF SystemInmode MD, Ltd.20161—
+7K151629Guardian 1000Quanta System Spa20150—
+7K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+7K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+7K142186Diode Laser Hair Removal SystemShenzhen Gsd Tech Co., Ltd.20151—
+7K141973Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd.201448—
+7K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+7K132754Neogen PSR SystemEnergist, Ltd.20132—
+7K131839DC 7Dc International, LLC20130—
+7K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+7K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+7K130465EPIC 10SBiolase Technology, Inc.20130—
+7K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+7K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+7K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+7K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+7K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+7K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+7K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+7K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+7K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+7K094049Stlase Diode LaserDental Photonics, Inc.201023—