510(k) Report

Devices descending from K050047

109 later devices reach Cutera Optional Pulsed Light Hand Piece Family through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K233099GladiatorRohrer Aesthetics, LLC20240—
+10K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+10K231971Deka Physiq 360El.En S.P.A.20230—
+10K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+10K182741SculpSureCynosure20195—
+10K172144CoolSculpting SystemZeltiq Aesthetics20177—
+11K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+11K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+11K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805