510(k) Report

Devices descending from K944090

1,155 later devices reach Candela Alex Lazr Q-Switched Alexandrite Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+8K232708Intense pulsed light therapy deviceHebei Zhemai Technology Co., Ltd.20230—
+8K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+8K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+8K223727LavieenWontech Co., Ltd.20234—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+8K230293TheraFace MaskTherabody, Inc.202316—
+8K222556BTL-785XBTL Industries, Inc.20235—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K223893Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V.20235—
+8K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.20239—
+8K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc.20222—
+8K221444LED Eye Perfector, model: EY-36A, EY-36BLight Tree Ventures Europe B.V.20223—
+8K222377Led Mask Platinum MdCellreturn Co., Ltd.20224—
+8K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+8K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+8K221427V-LaserWontech Co., Ltd.20222—
+8K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+8K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+8K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+8K212663Helios IV 785Laseroptek Co., Ltd.20223—
+8K210084SilkroHironic Co., Ltd.20223—
+8K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+8K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+8K212155TheraFace LEDTheragun, Inc.202142—
+8K210965reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+8K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+8K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+8K212082PicoreBio-Med USA, Inc.20210—
+8K212238TheraFace MicrocurrentTheragun, Inc.20210—
+8K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+8K210226PicoSure WorkstationCynosure, LLC20213—
+8K201685PotenzaJeisys Medical, Inc.20219—
+8K201735PlaDuo SystemShenB Co., Ltd.20203—
+8K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+8K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+8K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+8K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+8K201111GentleMax Pro PlusCandela Corporation20203—
+8K200110SANDRO DualWontech Co., Ltd.20202—
+8K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+8K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+8K191685PicoWay Laser SystemCandela Corporation201920—
+8K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+8K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+8K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+8K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+8K190443MMSphereGalactic Beauty, LLC201942—
+8K183452Vbeam Prima Laser SystemCandela Corp.20191—
+8K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+8K182997enlighten III Laser SystemCutera, Inc.20180—
+8K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+8K182669Youlaser CO2Quanta System Spa20181—
+8K181510Echolaser X4El.En Electronic Engineering Spa20183—
+8K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+8K181272Picocare FamilyWontech Co., Ltd.20188—
+8K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K173700PICOPLUS Laser SystemLutronic Corporation20187—
+8K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+8K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+8K170984LG Beauty Led MaskLg Electronics201793—
+8K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+8K170637sensiFirmEl Global Trade, Ltd.20173—
+8K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+8K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+8K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+8K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+8K161185LUCERNA Dental LaserViax Dental Lab20160—
+8K161043Profound SystemSyneron Candela Corporation20160—
+8K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+8K161669Waterlase ExpressBiolase, Inc.201621—
+8K153568InMode Plus SystemInmode MD, Ltd.201618—
+8K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+8K152737Lite TouchFocus Medical, LLC20160—
+8K160691Acne Light Therapy WandZuko, Inc.201650—
+8K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+8K151306SoleaConvergent Dental, Inc.20151—
+8K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+8K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+8K150027CYMAWhitecap Technologies, LLC20150—
+8K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+8K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+8K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+8K132754Neogen PSR SystemEnergist, Ltd.20132—
+8K131839DC 7Dc International, LLC20130—
+8K130420SOLEAConvergent Dental, Inc.201321
+8K130465EPIC 10SBiolase Technology, Inc.20130—
+8K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+8K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+8K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+8K110375Blueshine's Gold SeriesBlueshine Srl20124—
+8K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+8K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+8K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+8K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+8K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+8K082938EzlaseBiolase Technology, Inc.200850—