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
+7K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+7K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+7K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+7K151629Guardian 1000Quanta System Spa20150—
+7K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+7K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+7K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+7K150035V10 systemViora, Ltd.201531—
+7K150326PicoWay Laser SystemCandela Corporation201568—
+7K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+7K143105Picosure WorkstationCynosure, Inc.201549—
+7K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+7K142289PK SpatulaGyrus Acmi, Inc.20141—
+7K141555AdvantageLutronic Corporation201414—
+7K142372Pico Way Laser SystemCandela Corpation201470—
+7K140120EPIC 10Biolase, Inc.20141—
+7K140837Lucid LYBio-Med USA, Inc.20140—
+7K140719Picosure WorkstationCynosure, Inc.201450—
+7K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+7K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+7K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+7K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+7K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+7K122493GenesisplusCutera, Inc.201318—
+7K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+7K123889Acleara, TheraclearTheravant Corporation20130—
+7K121327Diolase 10SBiolase Technology, Inc.20132—
+7K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+7K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+7K121678DTADGyrus Acmi, Inc.20122—
+7K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+7K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+7K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+7K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+7K103775Peak Suction CoagulatorPeak Surgical, Inc.20111—
+7K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+7K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+7K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+7K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+7K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+7K091674Arthrocare Coblator IQ SystemArthrocare Corp.20101—
+7K080844G3 Generator and Accessories-Dissector Plasma KnifeGyrus Acmi, Inc.20091—
+7K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+7K083008CoolskinElbio Co., Ltd.20092—
+7K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+7K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+7K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+7K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+7K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+7K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+7K080735CryominiZimmer Elektromedizin GmbH20081—
+7K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+7K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+7K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+7K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+7K063828Diomed Delta 25Diomed, Ltd.20075—
+7K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+7K062369Iridex Oculight TXIridex Corp200673—
+7K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+7K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.20056—
+7K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+7K050673Candela Family of Pulse Dye Laser SystemsCandela Corp.20051332
+7K040384Mydon CWavelight Laser Technologie AG200451—
+7K033257Arthrocare Ent Plasma WandsArthrocare Corp.200342—
+8K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+8K252723Dynamis Pro FamilyFotona D.O.O.20260—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K262269CO2 Laser System (MBT- CO2 Laser)Beijing Mega Beauty Technology Co., Ltd.20260—
+8K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+8K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC20260—
+8K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.20260—
+8K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.20260—
+8K261202ENTire IRE SystemEntire Medical, Ltd.20260—
+8K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.20260—
+8K260257CO2 Laser SystemSanhe Meditech Co., Ltd.20260—
+8K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—
+8K253920CO2 Laser Treatment Machine (CFR3M1)Haidari Beauty Technology (Beijing) Co., Ltd.20260—
+8K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+8K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+8K253279Feather/numiere 05 06 07 (05)Heat IN A Click, LLC20250—
+8K252187Aura Glide (FC40)Aura Medical, LLC20250—
+8K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd.20251—
+8K250998CO2 Laser Therapy System (Model: LFS-D9U)Sanhe Lefis Electronics Co., Ltd.20250—
+8K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+8K251334New Doublo 2.0Hironic Co., Ltd.20250—
+8K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+8K251843Erchonia EVRLErchonia Corporation20250—
+8K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+8K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+8K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+8K250532Solawave 2-in-1 Skincare Mini (Model: 61043)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+8K251094Alma VeilWontech Co., Ltd.20250—
+8K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+8K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+8K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.20250—