510(k) Report

Devices descending from K910037

352 later devices reach Coherent Holmium:Yag Surgical Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+11K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+11K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+11K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+11K250734OptiLUV DevicePollogen, Ltd.20250—
+11K243139Reverso Pro SystemIndiba S. A. U.20250—
+11K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+11K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+11K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+11K233024Alma HarmonyAlma Lasers, Inc.20241—
+11K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+11K221571InMode Multi-systemInMode, Ltd.20222—
+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—
+12K252561BTL-754FFBTL Industries, Inc.20260—
+12K251632Optimas MAX SystemInMode, Ltd.20251—
+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—
+13K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+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—