510(k) Report

Devices descending from K954031

751 later devices reach Compu-Blend Epilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+9K232236EchoQuanta System Spa20230—
+9K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+9K231054V-LaserWontech Co., Ltd.20231—
+9K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+9K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+9K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+9K223540AvalancheLase FamilyFotona D.O.O.20230—
+9K223110truSculpt iDCutera, Inc.20221—
+9K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+9K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+9K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+9K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+9K213267Dynamis Pro FamilyFotona D.O.O.20222—
+9K212663Helios IV 785Laseroptek Co., Ltd.20223—
+9K210084SilkroHironic Co., Ltd.20223—
+9K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+9K213350mJOULE System and AccessoriesSciton, Inc20220—
+9K211681EONDominion Aesthetic Technologies, Inc.20221—
+9K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+9K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+9K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+9K212107ReversoIntelis Instruments, Ltd.20211—
+9K212331BodySculpRohrer Aesthetics, LLC20211—
+9K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+9K211107BTL-899 FPBTL Industries, Inc.20213—
+9K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+9K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+9K210226PicoSure WorkstationCynosure, LLC20213—
+9K203788DermaV Laser SystemLutronic Corporation202101
+9K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+9K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+9K201685PotenzaJeisys Medical, Inc.20219—
+9K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+9K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+9K201735PlaDuo SystemShenB Co., Ltd.20203—
+9K200693K2 MobileHulaser, Inc.20202—
+9K202172StarWalkerFotona D.O.O.20203—
+9K202041Opera EvoQuanta System Spa20200—
+9K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+9K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+9K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+9K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+9K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+9K193486Epic 980Biolase, Inc.20202—
+9K193426Elite iQCynosure, LLC20201—
+9K200234Surgical laser fibersQuanta System Spa20202—
+9K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+9K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+9K191086ExciplexClarteis20194—
+9K191685PicoWay Laser SystemCandela Corporation201920—
+9K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+9K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+9K183156V-LaserWontech Co., Ltd.20193—
+9K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+9K182997enlighten III Laser SystemCutera, Inc.20180—
+9K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+9K181518Sebacia MicroparticlesSebacia, Inc.20180—
+9K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+9K181272Picocare FamilyWontech Co., Ltd.20188—
+9K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+9K173700PICOPLUS Laser SystemLutronic Corporation20187—
+9K180044SIROLaser BlueDentsply Sirona201812—
+9K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+9K171262TempSureCynosure, Inc.201716—
+9K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+9K171111SculpsureCynosure, Inc.201710—
+9K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+9K163197Cook Holmium Laser FiberCook Incorporated20170—
+9K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+9K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+9K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+9K163128Epic ProBiolase, Inc.201716—
+9K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+9K162781Magma SparkFormatk Systems, Ltd.20160—
+9K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+9K161661Thermi RF AccessoriesThermi20163—
+9K160368EVO platformQuanta System Spa201636—
+9K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+9K151793InMode RF SystemInmode MD, Ltd.20161—
+9K152012EVO platformQuanta System Spa201537—
+9K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+9K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+9K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+9K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+10K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+10K252723Dynamis Pro FamilyFotona D.O.O.20260—
+10K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K261570Picosure WorkstationCynosure, LLC20260—
+10K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+10K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+10K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+10K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+10K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+10K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+10K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+10K252369Boston Pico755Boston Aesthetics, Inc.20260—
+10K253342PICO-KSpeclipse, Inc.20251—
+10K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+10K253344Bellus-QSpeclipse, Inc.20250—