510(k) Report

Devices descending from K031988

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K243854Contour Light (CL-100)Contour Research, LLC20261—
+7K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+7K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+7K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+7K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+7K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+7K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+7K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+7K250189AdvaTxAdvalight Aps20250—
+7K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+7K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+7K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+7K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+7K233344Regenalase Laser SystemIpg Medical20240—
+7K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+7K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+7K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+7K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+7K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+7K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+7K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+7K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+7K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+7K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+7K223110truSculpt iDCutera, Inc.20221—
+7K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+7K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+7K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+7K210183Waterlase iPLusBiolase, Inc.20220—
+7K211681EONDominion Aesthetic Technologies, Inc.20221—
+7K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+7K212331BodySculpRohrer Aesthetics, LLC20211—
+7K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+7K211107BTL-899 FPBTL Industries, Inc.20213—
+7K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+7K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+7K193367elysion-proHigh Technology Products S.L.U20203—
+7K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+7K192430Epic 980Biolase, Inc.20195—
+7K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+7K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+7K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+7K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+7K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+7K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+7K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+7K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+7K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+7K180508Joule SystemSciton, Inc20183—
+7K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+7K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+7K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+7K171702Exciplex308nmClarteis20175—
+7K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+7K171111SculpsureCynosure, Inc.201710—
+7K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+7K170500SIROLaser Advance+Dentsply Sirona201721—
+7K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+7K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+7K161185LUCERNA Dental LaserViax Dental Lab20160—
+7K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+7K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+7K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+7K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+7K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+7K141237Harmony LiteAlma, Inc.20154—
+7K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+7K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+7K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+7K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+7K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+7K124064Young AgainEspansione Marketing S.P.A20131—
+7K131839DC 7Dc International, LLC20130—
+7K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+7K130465EPIC 10SBiolase Technology, Inc.20130—
+7K111689StlaseDental Photonics, Inc.201222—
+8K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+8K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+8K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+8K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+8K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+8K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+8K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+8K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+8K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+8K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+8K251730LIA Console (542-7)Leadoptik, Inc.20250—
+8K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+8K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+8K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+8K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+8K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+8K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+8K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+8K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—