510(k) Report

Devices descending from K040081

415 later devices reach Palomar Luxv Handpiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K212331BodySculpRohrer Aesthetics, LLC20211—
+10K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+10K192970SlimusHironic Co., Ltd.20200—
+10K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+10K171992SculpSureCynosure, Inc.20178—
+10K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+11K233099GladiatorRohrer Aesthetics, LLC20240—
+11K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+11K231971Deka Physiq 360El.En S.P.A.20230—
+11K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+11K182741SculpSureCynosure20195—
+11K172144CoolSculpting SystemZeltiq Aesthetics20177—
+12K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+12K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+12K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805