510(k) Report

Devices descending from K964760

908 later devices reach Dornier Medilas Fiber Tome Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K251254Ignite RF SystemInMode, Ltd.20260—
+11K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd.20260—
+11K252877SANDRO DualWontech Co., Ltd.20250—
+11K252367InbellaMulti SystemInbella Medical, Inc.20250—
+11K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+11K251334New Doublo 2.0Hironic Co., Ltd.20250—
+11K250734OptiLUV DevicePollogen, Ltd.20250—
+11K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+11K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+11K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+11K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+11K242349FoLixLumenis Be, Ltd.20240—
+11K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+11K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+11K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+11K240752Deka ToroEl.En S.P.A.20240—
+11K233766Geneo X ElitePollogen, Ltd.20240—
+11K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+11K233642InMode RF SystemInMode, Ltd.20244—
+11K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+11K232424CurrentBody Skin RFEl Global Trade, Ltd.20240—
+11K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+11K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+11K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+11K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+11K223110truSculpt iDCutera, Inc.20221—
+11K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+11K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+11K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+11K211107BTL-899 FPBTL Industries, Inc.20213—
+11K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH202114
+11K200241TempSure SystemCynosure, LLC202013—
+11K183450EmBody SystemInmode MD, Ltd.20198—
+11K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+11K180406Ellipse YdunEllipse A/S20180—
+11K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+11K163373PK AIMGyrus Acmi, Inc.20161—
+11K132297EM Sinus Dilation SystemMedtronic Xomed, Inc.20135—
+11K120280Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc.20122—
+11K121351Sinus Dilation SystemEntrigue Surgical, Inc.20128—
+11K112506Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201121—
+11K111875Relieva Spin Sinus Dilation SystemAcclarent, Inc.20117—
+11K111254Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc.20117—
+11K110158Illuminating Sinus SeekerEntellus Medical, Inc.20113—
+12K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+12K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+12K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+12K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+12K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+12K240780InMode RF SystemInMode, Ltd.20243—
+12K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+12K212891TempSure SystemCynosure, LLC20221—
+12K213344BTL-899ABTL Industries, Inc.20222—
+12K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+12K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+12K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+12K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+12K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+12K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+12K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+12K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+12K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+12K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+12K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+12K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—
+12K140160Relieva Scout Sinus Dilation SystemAcclarent, Inc.20140—
+12K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+12K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp.20130—
+12K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201220—
+12K113522Pathassist Light SeekerEntellus Medical, Inc.20122—
+13K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+13K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+13K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+13K243737Inbella RF SystemInbella Medical, Inc.20250—
+13K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+13K230467BTL-899FBTL Industries, Inc.20231—
+13K230167BACK 4Swims America Corp20230—
+13K230037BACK 3Swims America Corp20230—
+13K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+13K223292TempSure SystemCynosure, LLC20220—
+13K213889PicoStarAsclepion Laser Technologies GmbH20220—
+13K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+13K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+13K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+13K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201217—
+13K120735Pathassit Light SeekerEntellus Medical, Inc.20121—
+14K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+14K202503ChromeQuanta System Spa202012—
+14K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+14K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+14K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+15K253765Vanish ProDdc Technologies, Inc.20260—
+15K241527Pastelle ProWontech Co., Ltd.20253—
+15K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+15K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+15K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+15K142252XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.201413—
+16K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+16K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc.201511—
+17K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—