510(k) Report

Devices descending from K153694

4 later devices reach Icare ic100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233516Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)Reichert, Inc.20240—
+1K190316Icare ic200Icare Finland OY20202—
+2K220852iCare IC200Icare Finland OY20221—
+3K241447iCare ST500 (TA04)Icare Finland OY20240—