510(k) Report

Devices descending from K963123

1,324 later devices reach Arthrocare Arthroscopic Eletrosurgery System (Model 980) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+13K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V.202310—
+13K182741SculpSureCynosure20195—
+13K172144CoolSculpting SystemZeltiq Aesthetics20177—
+13K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+13K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+14K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+14K213889PicoStarAsclepion Laser Technologies GmbH20220—
+14K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+14K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+14K201398SINUSPRIME Dilation SystemStryker Ent20200—
+14K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+14K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805
+14K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+15K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+15K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+15K202503ChromeQuanta System Spa202012—
+16K253765Vanish ProDdc Technologies, Inc.20260—
+16K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—
+16K241527Pastelle ProWontech Co., Ltd.20253—
+16K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+16K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+16K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+17K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—