510(k) Report

Devices descending from K951910

480 later devices reach Odyssey HO:Yag Surgical Laser Systems & Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+8K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+8K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+8K22079410PLTentech Co., Ltd.20220—
+8K212790XLase PlusBiotec Italia, Srl20220—
+8K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+8K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+8K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH202114
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K200616E>EyeCE-Swin20200—
+8K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+8K180406Ellipse YdunEllipse A/S20180—
+8K170637sensiFirmEl Global Trade, Ltd.20173—
+8K163373PK AIMGyrus Acmi, Inc.20161—
+8K161043Profound SystemSyneron Candela Corporation20160—
+8K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+8K153568InMode Plus SystemInmode MD, Ltd.201618—
+8K132297EM Sinus Dilation SystemMedtronic Xomed, Inc.20135—
+8K120280Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc.20122—
+8K121351Sinus Dilation SystemEntrigue Surgical, Inc.20128—
+8K112506Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201121—
+8K111875Relieva Spin Sinus Dilation SystemAcclarent, Inc.20117—
+8K111254Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc.20117—
+8K110158Illuminating Sinus SeekerEntellus Medical, Inc.20113—
+9K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+9K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+9K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+9K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+9K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+9K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+9K191855EmFace DeviceInmode MD, Ltd.20191—
+9K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+9K181095RF-ReliefEl Global Trade, Ltd.20181—
+9K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+9K172302InMode PLUS SystemInmode MD, Ltd.201713—
+9K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+9K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+9K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+9K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+9K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—
+9K140160Relieva Scout Sinus Dilation SystemAcclarent, Inc.20140—
+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—
+10K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+10K250734OptiLUV DevicePollogen, Ltd.20250—
+10K243139Reverso Pro SystemIndiba S. A. U.20250—
+10K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+10K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+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—
+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—
+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—