510(k) Report

Devices descending from K974789

653 later devices reach Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L 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—
+10K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+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—
+10K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+10K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+10K191855EmFace DeviceInmode MD, Ltd.20191—
+10K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+10K181095RF-ReliefEl Global Trade, Ltd.20181—
+10K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+10K172302InMode PLUS SystemInmode MD, Ltd.201713—
+10K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+10K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+10K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+10K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+10K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—
+10K140160Relieva Scout Sinus Dilation SystemAcclarent, Inc.20140—
+10K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+10K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp.20130—
+10K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201220—
+10K113522Pathassist Light SeekerEntellus Medical, Inc.20122—
+11K250734OptiLUV DevicePollogen, Ltd.20250—
+11K243737Inbella RF SystemInbella Medical, Inc.20250—
+11K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+11K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+11K183450EmBody SystemInmode MD, Ltd.20198—
+11K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+11K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201217—
+11K120735Pathassit Light SeekerEntellus Medical, Inc.20121—
+12K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+12K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+12K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+12K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+12K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+12K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+13K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+13K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+13K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+13K230167BACK 4Swims America Corp20230—
+13K230037BACK 3Swims America Corp20230—
+13K142252XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.201413—
+14K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc.201511—
+15K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+15K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+16K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+16K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+16K201398SINUSPRIME Dilation SystemStryker Ent20200—
+16K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+17K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+17K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+18K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—