510(k) Report

Devices descending from K993671

700 later devices reach Candela Sclero Long Pulse Dye Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+7K243957PicoalexWontech Co., Ltd.20250—
+7K241527Pastelle ProWontech Co., Ltd.20253—
+7K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+7K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+7K231948MediyagMedicreations, LLC20240—
+7K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+7K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+7K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+7K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+7K240752Deka ToroEl.En S.P.A.20240—
+7K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+7K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+7K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+7K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+7K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+7K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+7K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+7K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+7K222701MANTA LaserSqualus Med, Ltd.20222—
+7K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K22079410PLTentech Co., Ltd.20220—
+7K220853PicoWay Laser SystemCandela Corporation20221—
+7K221761SoleaConvergent Dental, Inc.202201
+7K221427V-LaserWontech Co., Ltd.20222—
+7K212790XLase PlusBiotec Italia, Srl20220—
+7K213594Echolaser X4Elesta S.P.A20221—
+7K212127PicocaremajestyWontech Co., Ltd.20226—
+7K213428EdgeProBiolase, Inc.20210—
+7K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+7K201773PicohiHironic Co., Ltd.20215—
+7K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+7K203299CellFX SystemPulse Biosciences, Inc.20214—
+7K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+7K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+7K200616E>EyeCE-Swin20200—
+7K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+7K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+7K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+7K191942MT One DiamondM&T S.R.L.20191—
+7K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K180359BTL-FR2000BTL Industries, Inc.20189—
+7K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+7K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+7K171702Exciplex308nmClarteis20175—
+7K172413MT ONEM&T S.R.L.20175—
+7K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+7K163222Discovery Pico FamilyQuanta System Spa201630—
+7K160075Accent XLAlma Lasers, Inc.20160—
+7K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+7K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+7K152611V20 systemViora, Ltd.20164—
+7K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+7K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+7K150664NeoLasSheaumann Laser, Inc.20151—
+7K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+7K151655CO2RE SystemSyneron Medical, Ltd.20151—
+7K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+7K150035V10 systemViora, Ltd.201531—
+7K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+7K140120EPIC 10Biolase, Inc.20141—
+7K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+7K133774AtovenBio-Med USA, Inc.20146—
+7K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+7K130501IntensifEndymed Medical, Ltd.201457—
+7K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+7K124064Young AgainEspansione Marketing S.P.A20131—
+7K131758Surgen UPollogen, Ltd.20135—
+7K132754Neogen PSR SystemEnergist, Ltd.20132—
+7K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—
+7K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+7K123573Youlaser CO2 LaserQuanta System Spa201319—
+7K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+7K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+7K121327Diolase 10SBiolase Technology, Inc.20132—
+7K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+7K120513Glow by EndymedEndymed Medical, Ltd.20125—
+7K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+7K113588Spectra Laser SystemLutronic Corporation201282—
+7K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—