510(k) Report

Devices descending from K032088

131 later devices reach Modification to Thermacool TC System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+11K233099GladiatorRohrer Aesthetics, LLC20240—
+11K240999Legend X Applicator VOPollogen, Ltd.20241—
+11K233849BTL-499BTL Industries, Inc.20240—
+11K233604BTL-785SBTL Industries, Inc.20243—
+11K230837PlazMagikAgnes Medical Co., Ltd.20240—
+11K233143PiXel8-RevealRohrer Aesthetics20240—
+11K233147PiXel8-RFRohrer Aesthetics20230—
+11K232223PlaDuo SystemShenB Co., Ltd.20230—
+11K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+11K212472AgeJetTriworks Group Srl20220—
+11K211000AcutronIlooda Co,., Ltd.20220—
+11K212607DarwinLuvo Medical Technologies, Inc.20210—
+12K254185Potenza PrimeJeisys Medical Incorporated20260—
+12K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+12K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+12K253803MILAN SystemLumenis Be, Ltd.20260—
+12K253750BTL-785NEHBTL Industries, Inc.20260—
+12K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+12K251254Ignite RF SystemInMode, Ltd.20260—
+12K252367InbellaMulti SystemInbella Medical, Inc.20250—
+12K251334New Doublo 2.0Hironic Co., Ltd.20250—
+12K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+12K242532BTL-785BNF-EBTL Industries, Inc.20241—
+12K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+12K233642InMode RF SystemInMode, Ltd.20244—
+13K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+13K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+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—
+14K243737Inbella RF SystemInbella Medical, Inc.20250—