510(k) Report

Devices descending from K024064

681 later devices reach Polaris DS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K241656Eneka SelectifTermosalud20241—
+7K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K233473Deka LotusEl.En S.P.A.20241—
+7K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+7K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+7K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+7K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+7K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+7K240313Oligio XWontech Co., Ltd.20241—
+7K233224Epilaser ProEpilady 2000, LLC20240—
+7K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+7K232106Air Gap FiberWontech Co., Ltd.20240—
+7K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+7K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+7K232236EchoQuanta System Spa20230—
+7K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+7K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+7K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+7K231054V-LaserWontech Co., Ltd.20231—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K223540AvalancheLase FamilyFotona D.O.O.20230—
+7K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+7K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+7K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K212663Helios IV 785Laseroptek Co., Ltd.20223—
+7K210084SilkroHironic Co., Ltd.20223—
+7K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+7K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+7K213350mJOULE System and AccessoriesSciton, Inc20220—
+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—
+7K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+7K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+7K210226PicoSure WorkstationCynosure, LLC20213—
+7K203788DermaV Laser SystemLutronic Corporation202101
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+7K201685PotenzaJeisys Medical, Inc.20219—
+7K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+7K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+7K201735PlaDuo SystemShenB Co., Ltd.20203—
+7K200693K2 MobileHulaser, Inc.20202—
+7K202172StarWalkerFotona D.O.O.20203—
+7K202041Opera EvoQuanta System Spa20200—
+7K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+7K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+7K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+7K193486Epic 980Biolase, Inc.20202—
+7K193426Elite iQCynosure, LLC20201—
+7K200234Surgical laser fibersQuanta System Spa20202—
+7K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+7K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+7K191086ExciplexClarteis20194—
+7K192224BTL-899Btl20198—
+7K191685PicoWay Laser SystemCandela Corporation201920—
+7K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+7K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+7K183156V-LaserWontech Co., Ltd.20193—
+7K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+7K182997enlighten III Laser SystemCutera, Inc.20180—
+7K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+7K181518Sebacia MicroparticlesSebacia, Inc.20180—
+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—
+7K180044SIROLaser BlueDentsply Sirona201812—
+7K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+7K171262TempSureCynosure, Inc.201716—
+7K172004truSculptCutera, Inc.20173—
+7K170637sensiFirmEl Global Trade, Ltd.20173—
+7K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+7K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+7K163197Cook Holmium Laser FiberCook Incorporated20170—
+7K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+7K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+7K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+7K163128Epic ProBiolase, Inc.201716—
+7K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+7K162781Magma SparkFormatk Systems, Ltd.20160—
+7K161043Profound SystemSyneron Candela Corporation20160—
+7K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+7K161661Thermi RF AccessoriesThermi20163—
+7K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+7K152731XP1100 RFBTL Industries, Inc.20160—
+7K153568InMode Plus SystemInmode MD, Ltd.201618—
+7K160368EVO platformQuanta System Spa201636—
+7K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+7K151793InMode RF SystemInmode MD, Ltd.20161—
+7K152012EVO platformQuanta System Spa201537—
+7K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—