510(k) Report

Devices descending from K053430

9 later devices reach Tono-Pen Avia Tonometer and Ocu-Shiled Tip Cover through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063873Icare Tonometer TA01ITiolat OY20078—
+2K163343Icare HOME tonometerIcare Finland OY20172—
+2K153694Icare ic100Icare Finland OY20164—
+3K233516Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)Reichert, Inc.20240—
+3K200966Icare HOME TonometerIcare Finland OY20201—
+3K190316Icare ic200Icare Finland OY20202—
+4K220852iCare IC200Icare Finland OY20221—
+4K211355iCare HOME2Icare Finland OY20220—
+5K241447iCare ST500 (TA04)Icare Finland OY20240—