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
+10K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+10K163373PK AIMGyrus Acmi, Inc.20161—
+10K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+10K150664NeoLasSheaumann Laser, Inc.20151—
+10K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+10K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+10K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+10K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+10K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+10K132297EM Sinus Dilation SystemMedtronic Xomed, Inc.20135—
+10K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—
+10K120280Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc.20122—
+10K121351Sinus Dilation SystemEntrigue Surgical, Inc.20128—
+10K111689StlaseDental Photonics, Inc.201222—
+10K112506Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201121—
+10K111875Relieva Spin Sinus Dilation SystemAcclarent, Inc.20117—
+10K111254Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc.20117—
+10K110158Illuminating Sinus SeekerEntellus Medical, Inc.20113—
+11K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+11K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…Shenzhen Qianyu Technology Co., Ltd.20260—
+11K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+11K252096Light Therapy Decollete Mask (1019135)Merchsource, LLC20250—
+11K250966CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+11K242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd20250—
+11K243737Inbella RF SystemInbella Medical, Inc.20250—
+11K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+11K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+11K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+11K214103Shani Darden LED light therapy maskHarpar Grace International202219—
+11K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+11K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+11K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+11K200693K2 MobileHulaser, Inc.20202—
+11K202503ChromeQuanta System Spa202012—
+11K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+11K193486Epic 980Biolase, Inc.20202—
+11K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+11K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+11K180044SIROLaser BlueDentsply Sirona201812—
+11K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+11K163128Epic ProBiolase, Inc.201716—
+11K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+11K160470SculpSureCynosure, Inc.201620—
+11K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+11K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+11K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+11K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+11K150724SculpSureCynosure, Inc.201521—
+11K150230SculpSureCynosure, Inc.201521—
+11K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—
+11K140160Relieva Scout Sinus Dilation SystemAcclarent, Inc.20140—
+11K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+11K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp.20130—
+11K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+11K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201220—
+11K113522Pathassist Light SeekerEntellus Medical, Inc.20122—
+12K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+12K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+12K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+12K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+12K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+12K234085LUNE™ PureHygieneEnamel Pure20241—
+12K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+12K230167BACK 4Swims America Corp20230—
+12K230037BACK 3Swims America Corp20230—
+12K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+12K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V.202310—
+12K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+12K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+12K211681EONDominion Aesthetic Technologies, Inc.20221—
+12K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+12K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+12K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+12K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+12K190743Venus BlissVenus Concept USA, Inc.20194—
+12K172771Epic Pro 940Biolase, Inc.20171—
+12K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+12K171111SculpsureCynosure, Inc.201710—
+12K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+12K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201217—
+12K120735Pathassit Light SeekerEntellus Medical, Inc.20121—
+13K260138LUNE PureHygieneEnamel Pure20260—
+13K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+13K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+13K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+13K222226EONDominion Aesthetic Technologies, Inc.20230—
+13K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+13K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+13K212331BodySculpRohrer Aesthetics, LLC20211—
+13K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+13K192970SlimusHironic Co., Ltd.20200—
+13K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+13K171992SculpSureCynosure, Inc.20178—
+13K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+13K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+13K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+13K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+14K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+14K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—