510(k) Report

Devices descending from K933804

803 later devices reach Lectron II Conductive Gel/Cadwell Electrode Gel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K161043Profound SystemSyneron Candela Corporation20160—
+6K160329InMode System MiniFX HandpieceInmode MD, Ltd.20167—
+6K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+6K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+6K153568InMode Plus SystemInmode MD, Ltd.201618—
+6K153229SuperbiumBios S.R.L.20162—
+6K153566Magma SystemFormatk Systems, Ltd.20162—
+6K152611V20 systemViora, Ltd.20164—
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K143559XP1000 RFBTL Industries, Inc.20157—
+6K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+6K141237Harmony LiteAlma, Inc.20154—
+6K142910Legacy BXVenus Concept USA, Inc.201411—
+6K142093V20 SystemViora, Ltd.201432—
+6K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+6K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+6K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+6K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+6K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+6K132976AdvatxAdvalight Aps20141—
+6K131758Surgen UPollogen, Ltd.20135—
+6K132754Neogen PSR SystemEnergist, Ltd.20132—
+6K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+6K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+6K111501I-Lipo SystemChromogenex Technologies Limited201215—
+6K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+6K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+6K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+6K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+6K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+6K090094Zeltiq SystemZeltiq Aesthetics200932—
+6K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+6K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+6K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+6K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+6K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+6K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+6K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+6K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+6K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+6K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+7K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+7K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+7K252561BTL-754FFBTL Industries, Inc.20260—
+7K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K250189AdvaTxAdvalight Aps20250—
+7K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+7K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+7K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+7K243929Oligio XWontech Co., Ltd.20250—
+7K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+7K231948MediyagMedicreations, LLC20240—
+7K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+7K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+7K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+7K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+7K234057NirvanaEl.En S.P.A.20240—
+7K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+7K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+7K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+7K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+7K231146AliTightAlic Iotech, LLC20230—
+7K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+7K22079410PLTentech Co., Ltd.20220—
+7K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+7K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+7K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+7K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+7K212790XLase PlusBiotec Italia, Srl20220—
+7K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+7K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+7K210183Waterlase iPLusBiolase, Inc.20220—
+7K213814Viveve 2.0 SystemViveve, Inc.20220—
+7K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+7K211461Family of Venus RF Systems - Venus FreedomVenus Concept USA, Inc.20210—
+7K211444CellFX SystemPulse Biosciences, Inc.20213—
+7K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+7K203728DarwinLuvo Medical Technologies, Inc.20211—
+7K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+7K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+7K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+7K202988Tixel SystemNovoxel, Ltd.20211—
+7K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+7K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+7K200616E>EyeCE-Swin20200—
+7K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+7K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+7K191065Venus VivaTMVenus Concept USA, Inc.20200—
+7K200241TempSure SystemCynosure, LLC202013—
+7K193367elysion-proHigh Technology Products S.L.U20203—
+7K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+7K192545PotenzaJeisys Medical Incorporated202020—
+7K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+7K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+7K192224BTL-899Btl20198—
+7K191855EmFace DeviceInmode MD, Ltd.20191—