510(k) Report

Devices descending from K973478

1,219 later devices reach Arthrocare Sinus Electrosurgery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K201398SINUSPRIME Dilation SystemStryker Ent20200—
+13K182741SculpSureCynosure20195—
+13K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+13K172144CoolSculpting SystemZeltiq Aesthetics20177—
+13K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+14K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+14K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+14K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+14K213889PicoStarAsclepion Laser Technologies GmbH20220—
+14K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+14K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805
+15K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—
+15K202503ChromeQuanta System Spa202012—
+16K253765Vanish ProDdc Technologies, 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—