510(k) Report

Devices descending from K011703

342 later devices reach Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… through their predicates, nearest generation first.

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