510(k) Report

Devices descending from K963339

675 later devices reach Coherent Ultrapulse CO2 Surgical Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+10K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+10K262877SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America20260—
+10K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+10K252877SANDRO DualWontech Co., 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—
+10K242349FoLixLumenis Be, Ltd.20240—
+10K240780InMode RF SystemInMode, Ltd.20243—
+10K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+10K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+10K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+10K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+10K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH202114
+10K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+10K170637sensiFirmEl Global Trade, Ltd.20173—
+10K163373PK AIMGyrus Acmi, Inc.20161—
+10K161043Profound SystemSyneron Candela Corporation20160—
+10K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+10K153568InMode Plus SystemInmode MD, Ltd.201618—
+10K132297EM Sinus Dilation SystemMedtronic Xomed, Inc.20135—
+10K120280Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc.20122—
+10K121351Sinus Dilation SystemEntrigue Surgical, Inc.20128—
+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—
+11K243737Inbella RF SystemInbella Medical, Inc.20250—
+11K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+11K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+11K191855EmFace DeviceInmode MD, Ltd.20191—
+11K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+11K181095RF-ReliefEl Global Trade, Ltd.20181—
+11K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+11K172302InMode PLUS SystemInmode MD, Ltd.201713—
+11K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+11K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+11K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+11K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+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—
+11K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201220—
+11K113522Pathassist Light SeekerEntellus Medical, Inc.20122—
+12K250734OptiLUV DevicePollogen, Ltd.20250—
+12K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+12K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+12K183450EmBody SystemInmode MD, Ltd.20198—
+12K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+12K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201217—
+12K120735Pathassit Light SeekerEntellus Medical, Inc.20121—
+13K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+13K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+13K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+13K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+13K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+13K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+14K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+14K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+14K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+14K230167BACK 4Swims America Corp20230—
+14K230037BACK 3Swims America Corp20230—
+14K142252XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.201413—
+15K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc.201511—
+16K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+16K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+17K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+17K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+17K201398SINUSPRIME Dilation SystemStryker Ent20200—
+17K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+18K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+18K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+19K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—