510(k) Report

Devices descending from K171637

3 later devices reach OpClear System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222695troCarWash™ SystemBiotex, Inc.20231—
+1K221824OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear…Cipher Surgical Limited20220—
+2K233442troCarWash™ SystemBiotex, Inc.20240—