510(k) Report

Devices descending from K031671

678 later devices reach Polaris WR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+5K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+5K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+5K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+5K243139Reverso Pro SystemIndiba S. A. U.20250—
+5K242532BTL-785BNF-EBTL Industries, Inc.20241—
+5K240897CellinewVIOL Co., Ltd.20240—
+5K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+5K231948MediyagMedicreations, LLC20240—
+5K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+5K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+5K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K233473Deka LotusEl.En S.P.A.20241—
+5K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K240313Oligio XWontech Co., Ltd.20241—
+5K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+5K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+5K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+5K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+5K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K223680Eneka ProTermosalud20230—
+5K222701MANTA LaserSqualus Med, Ltd.20222—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K22079410PLTentech Co., Ltd.20220—
+5K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K210084SilkroHironic Co., Ltd.20223—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K212107ReversoIntelis Instruments, Ltd.20211—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+5K201685PotenzaJeisys Medical, Inc.20219—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K201735PlaDuo SystemShenB Co., Ltd.20203—
+5K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+5K200616E>EyeCE-Swin20200—
+5K200104OxylightRaja Trading Company, Inc.202024—
+5K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+5K192224BTL-899Btl20198—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+5K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+5K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+5K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+5K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+5K172413MT ONEM&T S.R.L.20175—
+5K171262TempSureCynosure, Inc.201716—
+5K171227StarWalkerFotona D.O.O.20177—
+5K172004truSculptCutera, Inc.20173—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+5K162781Magma SparkFormatk Systems, Ltd.20160—
+5K161661Thermi RF AccessoriesThermi20163—
+5K152731XP1100 RFBTL Industries, Inc.20160—
+5K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K151793InMode RF SystemInmode MD, Ltd.20161—
+5K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+5K152714Quanta ForteQuanta System Spa201513—
+5K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+5K151629Guardian 1000Quanta System Spa20150—
+5K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+5K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+5K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+5K140120EPIC 10Biolase, Inc.20141—
+5K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+5K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+5K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+5K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+5K133837Viora V-TotalViora, Ltd.201433—
+5K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+5K123443Precise SHP Diode LaserCAO Group, Inc.20139—