510(k) Report

Devices descending from K200241

13 later devices reach TempSure System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+1K212891TempSure SystemCynosure, LLC20221—
+1K211639BTL-785WBTL Industries, Inc.20227—
+1K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+2K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+2K222556BTL-785XBTL Industries, Inc.20235—
+2K223292TempSure SystemCynosure, LLC20220—
+2K212607DarwinLuvo Medical Technologies, Inc.20210—
+3K233849BTL-499BTL Industries, Inc.20240—
+3K233604BTL-785SBTL Industries, Inc.20243—
+4K253750BTL-785NEHBTL Industries, Inc.20260—
+4K242532BTL-785BNF-EBTL Industries, Inc.20241—
+5K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—