510(k) Report

Devices descending from K021149

750 later devices reach Aurora DS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K250189AdvaTxAdvalight Aps20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K240897CellinewVIOL Co., Ltd.20240—
+6K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+6K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+6K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K240313Oligio XWontech Co., Ltd.20241—
+6K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+6K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+6K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+6K222556BTL-785XBTL Industries, Inc.20235—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K222701MANTA LaserSqualus Med, Ltd.20222—
+6K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K211639BTL-785WBTL Industries, Inc.20227—
+6K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K202288FinebeamSNJ Co., Ltd.20212—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+6K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+6K211461Family of Venus RF Systems - Venus FreedomVenus Concept USA, Inc.20210—
+6K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+6K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+6K193201BTL-785FBtl20208—
+6K200104OxylightRaja Trading Company, Inc.202024—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K192224BTL-899Btl20198—
+6K191855EmFace DeviceInmode MD, Ltd.20191—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K180359BTL-FR2000BTL Industries, Inc.20189—
+6K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+6K181095RF-ReliefEl Global Trade, Ltd.20181—
+6K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+6K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K172302InMode PLUS SystemInmode MD, Ltd.201713—
+6K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+6K172004truSculptCutera, Inc.20173—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+6K152731XP1100 RFBTL Industries, Inc.20160—
+6K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K151629Guardian 1000Quanta System Spa20150—
+6K151655CO2RE SystemSyneron Medical, Ltd.20151—
+6K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+6K150724SculpSureCynosure, Inc.201521—
+6K150230SculpSureCynosure, Inc.201521—
+6K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+6K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K142860Lumenis M22 SystemLumenis, Ltd.2015381
+6K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+6K142910Legacy BXVenus Concept USA, Inc.201411—
+6K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+6K140120EPIC 10Biolase, Inc.20141—
+6K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+6K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+6K133364Picosure WorkstationCynosure, Inc.201451—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+6K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+6K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+6K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+6K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+6K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+6K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—
+6K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+6K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+6K122966XP200Btl Industries, Ltd.20131—
+6K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+6K121346Picosure WorkstationCynosure, Inc.201287—
+6K121286EPIC 10Biolase Technology, Inc.201231—
+6K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+6K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—