510(k) Report

Devices descending from K981351

811 later devices reach Candela Gentlelase GL Dermatological Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+13K240780InMode RF SystemInMode, Ltd.20243—
+13K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+13K231971Deka Physiq 360El.En S.P.A.20230—
+13K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+13K182741SculpSureCynosure20195—
+13K172144CoolSculpting SystemZeltiq Aesthetics20177—
+14K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+14K243737Inbella RF SystemInbella Medical, Inc.20250—
+14K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+14K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805