510(k) Report

Devices descending from K951812

1,418 later devices reach Modified Coherent Ultrapulse CO2 Surgical Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V.202318—
+7K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…ArthroCare Corporation20230—
+7K222790F65 Laser SystemLumenis Be, Ltd.20233—
+7K222556BTL-785XBTL Industries, Inc.20235—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K223147myLEDmaskMyblend20234—
+7K230816Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20231—
+7K221865BTL-094BTL Industries, Inc.20230—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K210166Omnispec ED1000Medispec, Ltd.20230—
+7K221306SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed…Gyrus Acmi, Inc.202348
+7K223540AvalancheLase FamilyFotona D.O.O.20230—
+7K222701MANTA LaserSqualus Med, Ltd.20222—
+7K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+7K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+7K220385Intense Pulsed Light EquipmentBeijing Globalipl Development Co., Ltd.20220—
+7K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+7K221083Smartlux MiniMedmix Co., Ltd.20222—
+7K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+7K220729The Luminance RED Acne DeviceLuminance Medical Ventures, Inc.20221—
+7K211000AcutronIlooda Co,., Ltd.20220—
+7K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+7K213350mJOULE System and AccessoriesSciton, Inc20220—
+7K213534PHantom TrilogyResurgeonz, LLC20220—
+7K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+7K220020Cryo 7Zimmer Medizinsysteme GmbH20222—
+7K212611CO2 Laser EquipmentBeijing Globalipl Development Co., Ltd.20220—
+7K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+7K213841ENEO TOTALE (Model: ENEOT947)Premier North America, Inc.20222—
+7K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+7K211517Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT…Convergent Laser Technologies20210—
+7K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+7K211401SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser…Gyrus Acmi, Inc.202171
+7K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+7K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+7K203788DermaV Laser SystemLutronic Corporation202101
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K193266MIINMedico USA, Inc.20210—
+7K201685PotenzaJeisys Medical, Inc.20219—
+7K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+7K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+7K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+7K201735PlaDuo SystemShenB Co., Ltd.20203—
+7K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+7K202250Dermatological Carbon Dioxide Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd.20200—
+7K202428AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20201—
+7K201406PicowonWontech Co., Ltd.20200—
+7K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200786Venus EpileveVenus Concept USA, Inc.20200—
+7K200042CO2 Laser SystemBeijing Superlaser Technology Co., Ltd.20205—
+7K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+7K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+7K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+7K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+7K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60Quanta System Spa20205—
+7K192990Litho EvoQuanta System Spa20190—
+7K191086ExciplexClarteis20194—
+7K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd.20192—
+7K191518CO2 Laser SystemShenzhen Gsd Tech Co., Ltd.20191—
+7K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+7K183156V-LaserWontech Co., Ltd.20193—
+7K183247dpl FacewareLed Technologies, Inc.201910—
+7K183118dpl SpotLiteLed Technologies, Inc.201922—
+7K180875Poly RejuvMedtek Skincare, LLC20180—
+7K181518Sebacia MicroparticlesSebacia, Inc.20180—
+7K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845—
+7K180847Neutrogena Light Therapy Acne Mask+Johnson & Johnson Consumer, Inc.201844—
+7K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc.20185—
+7K180922Empower H100, Cyber Ho 100, Litho 100Quanta System Spa20186—
+7K1718212 Face / Face EvolutionHeat IN A Click201858—
+7K173677InMode VLazeInmode MD, Ltd.20183—
+7K173199PicoSure WorkstationCynosure, Inc.20189—
+7K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+7K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+7K171648BM.IrisBluecore Co., Ltd.20172—
+7K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+7K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+7K162755PicocareWontech Co., Ltd.20179—
+7K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+7K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+7K170068Softcure 96Wellray Medical Laser, Inc.20170—
+7K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+7K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+7K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.201755—
+7K163222Discovery Pico FamilyQuanta System Spa201630—
+7K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+7K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+7K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+7K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+7K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+7K152856Helios IIILaseroptek Co., Ltd.20165—
+7K160480PicoSure WorkstationCynosure, Inc.201620—
+7K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+7K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+7K152611V20 systemViora, Ltd.20164—