510(k) Report

Devices descending from DEN170072

5 later devices reach Enlight 1810 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211135Enlight 2100Timpel S.A.20224—
+2K222466AirTomBilab20230—
+2K222897Enlight 2100Timpel S.A.20232—
+3K250464Enlight 2100 (TPL-E2103-0)Timpel S.A.20250—
+3K243765LuMon (TM) SystemSentec AG20250—