510(k) Report

Devices descending from K971874

816 later devices reach Sharplan Epitouch Alexandrite Laser System (5000) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+14K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+14K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+14K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.20260—
+14K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+14K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+14K240780InMode RF SystemInMode, Ltd.20243—
+14K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+14K231971Deka Physiq 360El.En S.P.A.20230—
+14K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+14K182741SculpSureCynosure20195—
+14K172144CoolSculpting SystemZeltiq Aesthetics20177—
+15K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+15K243737Inbella RF SystemInbella Medical, Inc.20250—
+15K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+15K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805