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
+9K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+9K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+9K220853PicoWay Laser SystemCandela Corporation20221—
+9K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+9K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+9K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+9K212127PicocaremajestyWontech Co., Ltd.20226—
+9K201773PicohiHironic Co., Ltd.20215—
+9K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+9K210948Omnilux CLEARGlobalmed Technologies202139—
+9K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+9K202041Opera EvoQuanta System Spa20200—
+9K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+9K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+9K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+9K201111GentleMax Pro PlusCandela Corporation20203—
+9K200110SANDRO DualWontech Co., Ltd.20202—
+9K191855EmFace DeviceInmode MD, Ltd.20191—
+9K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+9K191629faceLITEIsmart Marketing Svcs, Ltd.201971—
+9K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+9K183452Vbeam Prima Laser SystemCandela Corp.20191—
+9K183671LG Pra.L Derma Led MaskLg Electronics.Inc201948—
+9K181510Echolaser X4El.En Electronic Engineering Spa20183—
+9K181095RF-ReliefEl Global Trade, Ltd.20181—
+9K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.20180—
+9K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+9K172302InMode PLUS SystemInmode MD, Ltd.201713—
+9K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+9K161825PK AIMGyrus Acmi, Inc.20162—
+9K161669Waterlase ExpressBiolase, Inc.201621—
+9K152737Lite TouchFocus Medical, LLC20160—
+9K142759PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc.20152—
+9K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+9K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+9K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+9K121286EPIC 10Biolase Technology, Inc.201231—
+9K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+9K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+9K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+9K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+9K102003Xpress Balloon DeviceEntellus Medical, Inc.201036—
+9K094049Stlase Diode LaserDental Photonics, Inc.201023—
+9K093007Entellus Medical Balloon DeviceEntellus Medical, Inc.201041—
+9K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+9K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+10K262877SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America20260—
+10K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.20260—
+10K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+10K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…Dongguan Miqiang Technology Co., Ltd.20260—
+10K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.20260—
+10K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.20260—
+10K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+10K260632Laser Thermal Therapy KitElesta S.P.A20260—
+10K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+10K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+10K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+10K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+10K252877SANDRO DualWontech Co., Ltd.20250—
+10K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.20250—
+10K252308LED Beauty Mask (RLBXX)Atop Lighting Co., Ltd.20250—
+10K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd.20252—
+10K252093Light Therapy Mask (1019055)Merchsource, LLC20250—
+10K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+10K250734OptiLUV DevicePollogen, Ltd.20250—
+10K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+10K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+10K250581KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+10K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+10K242382décoLITE LED DeviceiSMART Developments, Ltd.20246—
+10K240780InMode RF SystemInMode, Ltd.20243—
+10K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+10K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+10K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+10K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+10K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+10K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+10K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+10K230351LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd.202333—
+10K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V.20227—
+10K221946LED Light Therapy Mask (model: MK66R-B)Light Tree Ventures Europe B.V.202218—
+10K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+10K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+10K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.202241—
+10K213594Echolaser X4Elesta S.P.A20221—
+10K213889PicoStarAsclepion Laser Technologies GmbH20220—
+10K213428EdgeProBiolase, Inc.20210—
+10K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+10K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin202135—
+10K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+10K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH202114
+10K192430Epic 980Biolase, Inc.20195—
+10K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+10K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+10K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+10K183450EmBody SystemInmode MD, Ltd.20198—
+10K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+10K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+10K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+10K170500SIROLaser Advance+Dentsply Sirona201721—