510(k) Report

Devices descending from K950239

1,329 later devices reach Sensimatic 500SE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+14K192970SlimusHironic Co., Ltd.20200—
+14K171992SculpSureCynosure, Inc.20178—
+14K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+14K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+14K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+15K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+15K231971Deka Physiq 360El.En S.P.A.20230—
+15K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V.202310—
+15K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+15K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+15K201398SINUSPRIME Dilation SystemStryker Ent20200—
+15K182741SculpSureCynosure20195—
+15K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+15K172144CoolSculpting SystemZeltiq Aesthetics20177—
+15K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+16K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+16K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+16K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+16K213889PicoStarAsclepion Laser Technologies GmbH20220—
+16K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+16K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805
+17K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—
+17K202503ChromeQuanta System Spa202012—
+18K253765Vanish ProDdc Technologies, Inc.20260—
+18K241527Pastelle ProWontech Co., Ltd.20253—
+18K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+18K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+18K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+19K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—