510(k) Report

Devices descending from K951812

1,418 later devices reach Modified Coherent Ultrapulse CO2 Surgical Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K260100MOSES Raydar™Boston Scientific Corporation20260—
+6K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+6K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+6K253765Vanish ProDdc Technologies, Inc.20260—
+6K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+6K253917ARION ARC SystemPlasma Surgical, Inc.20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K253633Holmium Laser Therapeutic Apparatus (HZ-40)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20260—
+6K253342PICO-KSpeclipse, Inc.20251—
+6K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+6K253344Bellus-QSpeclipse, Inc.20250—
+6K252519CO2 Laser Therapy System (K106)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+6K252529Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110)…Boston Scientific Corporation20250—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K251759Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser…Boston Scientific Corporation20250—
+6K250165PastelleWontech Co., Ltd.20250—
+6K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+6K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+6K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+6K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+6K250183CO2 Laser System (CO2 Laser SST-L23)Zhuozhou Summer Star Technologies Co., Ltd.20250—
+6K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+6K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K250281Deka LotusEl.En S.P.A.20250—
+6K241527Pastelle ProWontech Co., Ltd.20253—
+6K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+6K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+6K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+6K241270BTL-754BTL Industries, Inc.20251—
+6K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+6K243139Reverso Pro SystemIndiba S. A. U.20250—
+6K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+6K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+6K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+6K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+6K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+6K240752Deka ToroEl.En S.P.A.20240—
+6K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+6K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+6K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+6K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+6K223727LavieenWontech Co., Ltd.20234—
+6K231718Holmium Medical LaserAllengers Global Healthcare Private Limited20230—
+6K231394Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd.20232—
+6K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+6K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+6K223680Eneka ProTermosalud20230—
+6K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+6K222369PURE LaserEndymed Medical, Ltd.20220—
+6K213674CellFX SystemPulse Biosciences, Inc.20220—
+6K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+6K221761SoleaConvergent Dental, Inc.202201
+6K222075CellFX SystemPulse Biosciences, Inc.20220—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K221671CellFX® SystemPulse Biosciences, Inc.20220—
+6K213252Dornier ThulioDornier Medtech America, Inc.20220—
+6K210084SilkroHironic Co., Ltd.20223—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+6K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K211639BTL-785WBTL Industries, Inc.20227—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K212107ReversoIntelis Instruments, Ltd.20211—
+6K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+6K212703AcuPulse CO2 Laser System, Delivery Devices and AccessoriesLumenis, Ltd.20210—
+6K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+6K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+6K202955Contour Light CL-100Contour Research, LLC20218—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K202702FLARE Single-Use Surgical Laser FiberRealton (Suzhou) Medical Technology Co., Ltd.20210—
+6K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter…ArthroCare Corporation20202—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K192275invisa-RED ELITEIR Technology, LLC20201—
+6K201663AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20202—
+6K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+6K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+6K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+6K193426Elite iQCynosure, LLC20201—
+6K192545PotenzaJeisys Medical Incorporated202020—
+6K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—