510(k) Report

Devices descending from K951812

1,418 later devices reach Modified Coherent Ultrapulse CO2 Surgical Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+14K231971Deka Physiq 360El.En S.P.A.20230—
+14K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+14K182741SculpSureCynosure20195—
+14K172144CoolSculpting SystemZeltiq Aesthetics20177—
+14K142252XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.201413—
+15K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+15K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+15K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805
+15K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc.201511—
+16K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+16K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+17K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+17K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+17K201398SINUSPRIME Dilation SystemStryker Ent20200—
+17K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+18K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+18K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+19K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—