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
+8K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+8K142350PK J-HookGyrus Acmi, Inc.201511
+8K142525PK Lap LoopOlympus Winter & Ibe GmbH20140—
+8K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+8K131839DC 7Dc International, LLC20130—
+8K131205Arthrocare Head and Neck Coblation WandArthroCare Corporation20130—
+8K130305Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeLina Medical Aps20130—
+8K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+8K130465EPIC 10SBiolase Technology, Inc.20130—
+8K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+8K122605PKS BillGyrus Acmi, Inc.20121—
+8K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+8K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+8K102366Finess EndoscopeEntellus Medical, Inc.20110—
+8K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+8K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+8K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+8K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc.201031
+8K091534Lightlas Model 532Lightmed Corp.200972—
+8K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+8K090094Zeltiq SystemZeltiq Aesthetics200932—
+8K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+8K082938EzlaseBiolase Technology, Inc.200850—
+8K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+8K081766PKS Omni InstrumentGyrus-Acmi L.P.200831
+8K081954Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector CableGyrus Acmi, Inc.20080—
+8K071759LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand…Live Tissue Connect, Inc.20080—
+8K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+8K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+8K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc.200842—
+8K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+8K063538Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control…Arthrocare Corp.200640—
+8K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical20060—
+8K050218Wavelight SinonWavelight Laser Technologie AG20050—
+9K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+9K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+9K254185Potenza PrimeJeisys Medical Incorporated20260—
+9K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+9K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited20260—
+9K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America20261—
+9K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+9K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+9K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+9K261570Picosure WorkstationCynosure, LLC20260—
+9K253803MILAN SystemLumenis Be, Ltd.20260—
+9K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—
+9K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+9K260150Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)Nooance20260—
+9K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+9K253750BTL-785NEHBTL Industries, Inc.20260—
+9K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+9K253951Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B)…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20260—
+9K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+9K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+9K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+9K253712LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063…Shenzhen Rainbow Technology Co., Ltd.20261—
+9K252369Boston Pico755Boston Aesthetics, Inc.20260—
+9K251254Ignite RF SystemInMode, Ltd.20260—
+9K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—
+9K253135LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1…Dongguan Yijiaming Technology Co., Ltd.20250—
+9K251730LIA Console (542-7)Leadoptik, Inc.20250—
+9K252983Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)Shenzhen Goodwind Technology Development Co., Ltd.20250—
+9K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd.20250—
+9K252771Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+9K253123CuRAS hybridClassys, Inc.20250—
+9K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.20251—
+9K252642Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd.20250—
+9K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+9K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—
+9K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+9K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+9K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+9K252367InbellaMulti SystemInbella Medical, Inc.20250—
+9K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+9K251100Ipgtfl-02Ipg Medical Corporation20250—
+9K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+9K251871FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC20250—
+9K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+9K250504Leonardo DusterCeramoptec GmbH20250—
+9K243978LED Facial MaskShenzhen Sunsred Technology Co.,Ltd20250—
+9K250880Led Light Mask (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd.20250—
+9K244020Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd.20250—
+9K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+9K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.20253—
+9K243957PicoalexWontech Co., Ltd.20250—
+9K243587PureLift GLOWXtreem Pulse, LLC20251—
+9K243330LYMA Laser PROLyma Life, Ltd.20250—
+9K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+9K242532BTL-785BNF-EBTL Industries, Inc.20241—
+9K242638LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.20241—
+9K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+9K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+9K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+9K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+9K233642InMode RF SystemInMode, Ltd.20244—
+9K233556LED Eye mask (EY-20R, A20, EY-20N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+9K232795Led Mask Platinum Exclusive MDStg24 Co., Ltd.20230—