510(k) Report

Devices descending from K020453

1,018 later devices reach Palomar Estelux Pulsed Light System and Palomar Coolroller through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K171992SculpSureCynosure, Inc.20178—
+11K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+12K243737Inbella RF SystemInbella Medical, Inc.20250—
+12K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+12K231971Deka Physiq 360El.En S.P.A.20230—
+12K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+12K202503ChromeQuanta System Spa202012—
+12K182741SculpSureCynosure20195—
+12K172144CoolSculpting SystemZeltiq Aesthetics20177—
+13K253765Vanish ProDdc Technologies, Inc.20260—
+13K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+13K241527Pastelle ProWontech Co., Ltd.20253—
+13K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+13K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+13K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+13K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+13K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805
+14K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—