510(k) Report

Devices descending from K002308

345 later devices reach Omnipulse Holmium Laser System, Model 1210; Omnipulse Max Holmium Laser… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+9K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp.20130—
+9K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201220—
+9K113522Pathassist Light SeekerEntellus Medical, Inc.20122—
+10K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+10K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+10K250734OptiLUV DevicePollogen, Ltd.20250—
+10K243139Reverso Pro SystemIndiba S. A. U.20250—
+10K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+10K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+10K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+10K233024Alma HarmonyAlma Lasers, Inc.20241—
+10K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+10K221571InMode Multi-systemInMode, Ltd.20222—
+10K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+10K183450EmBody SystemInmode MD, Ltd.20198—
+10K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+10K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201217—
+10K120735Pathassit Light SeekerEntellus Medical, Inc.20121—
+11K252561BTL-754FFBTL Industries, Inc.20260—
+11K251632Optimas MAX SystemInMode, Ltd.20251—
+11K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+11K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+11K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+11K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+11K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+12K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+12K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+12K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+12K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+12K230167BACK 4Swims America Corp20230—
+12K230037BACK 3Swims America Corp20230—
+12K142252XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.201413—
+13K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc.201511—
+14K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+14K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+15K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+15K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+15K201398SINUSPRIME Dilation SystemStryker Ent20200—
+15K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+16K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+16K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+17K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—