510(k) Report

Devices descending from K041999

111 later devices reach Gyrus Plasma Skin Resurfacing System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K252367InbellaMulti SystemInbella Medical, Inc.20250—
+11K251334New Doublo 2.0Hironic Co., Ltd.20250—
+11K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+11K242532BTL-785BNF-EBTL Industries, Inc.20241—
+11K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+11K233642InMode RF SystemInMode, Ltd.20244—
+12K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+12K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+12K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+12K240780InMode RF SystemInMode, Ltd.20243—
+13K243737Inbella RF SystemInbella Medical, Inc.20250—