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
+5K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+5K063249BeamaxMedic Sharplight, Ltd.200758—
+5K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+5K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+5K052310Cryoflow 700, Cryoflow 1000Uniphy Elektromedizin GmbH & Co. KG20060—
+5K060395Cryo, Model V6.0Zimmer Elektromedizin GmbH20069—
+5K052442Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd.200612—
+5K053324Chromolite SystemChromogenex Plc200631—
+5K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+5K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+5K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp.2005136—
+5K041969Aurora DSSyneron Medical, Ltd.2004302—
+5K032397Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd.20042—
+5K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+5K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+5K033461Candela Vbeam Pulse Dye Laser SystemCandela Corp.2004316—
+5K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+5K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+5K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+5K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+5K023881Profile 1064 Laser SystemSciton, Inc2003227—
+6K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+6K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.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—
+6K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+6K253342PICO-KSpeclipse, Inc.20251—
+6K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+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—
+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—
+6K250165PastelleWontech Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+6K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+6K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+6K250189AdvaTxAdvalight Aps20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K250281Deka LotusEl.En S.P.A.20250—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+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—
+6K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+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—
+6K242132FreddoFabinject Lndustria E Comercio Lmportacao E Exportacao Ltda20240—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+6K240752Deka ToroEl.En S.P.A.20240—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+6K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+6K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+6K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+6K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+6K231394Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd.20232—
+6K230077LaserMENeauvia North America20232—
+6K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+6K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+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—
+6K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+6K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+6K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K213350mJOULE System and AccessoriesSciton, Inc20220—
+6K220020Cryo 7Zimmer Medizinsysteme GmbH20222—
+6K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+6K211444CellFX SystemPulse Biosciences, Inc.20213—
+6K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+6K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+6K202955Contour Light CL-100Contour Research, LLC20218—
+6K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+6K202988Tixel SystemNovoxel, Ltd.20211—
+6K193201BTL-785FBtl20208—
+6K192275invisa-RED ELITEIR Technology, LLC20201—
+6K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+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
+6K191065Venus VivaTMVenus Concept USA, Inc.20200—