510(k) Report

Devices descending from K092191

12 later devices reach Exilis, Model 5000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222556BTL-785XBTL Industries, Inc.20235—
+1K211639BTL-785WBTL Industries, Inc.20227—
+1K192621Medical RFTriworks Group Srl20200—
+1K193201BTL-785FBtl20208—
+1K122966XP200Btl Industries, Ltd.20131—
+2K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+2K233849BTL-499BTL Industries, Inc.20240—
+2K233604BTL-785SBTL Industries, Inc.20243—
+2K143109XP300BTL Industries, Inc.20150—
+3K253750BTL-785NEHBTL Industries, Inc.20260—
+3K242532BTL-785BNF-EBTL Industries, Inc.20241—
+4K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—