510(k) Report

Devices descending from K043402

124 later devices reach Thermage Thermacool System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K230837PlazMagikAgnes Medical Co., Ltd.20240—
+8K233143PiXel8-RevealRohrer Aesthetics20240—
+8K233147PiXel8-RFRohrer Aesthetics20230—
+8K232223PlaDuo SystemShenB Co., Ltd.20230—
+8K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+8K212472AgeJetTriworks Group Srl20220—
+8K211000AcutronIlooda Co,., Ltd.20220—
+8K212607DarwinLuvo Medical Technologies, Inc.20210—
+9K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+9K254185Potenza PrimeJeisys Medical Incorporated20260—
+9K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+9K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+9K253803MILAN SystemLumenis Be, Ltd.20260—
+9K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+9K251254Ignite RF SystemInMode, Ltd.20260—
+9K252367InbellaMulti SystemInbella Medical, Inc.20250—
+9K251334New Doublo 2.0Hironic Co., Ltd.20250—
+9K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K233642InMode RF SystemInMode, Ltd.20244—
+10K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+10K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+10K240780InMode RF SystemInMode, Ltd.20243—
+11K243737Inbella RF SystemInbella Medical, Inc.20250—