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510(k) K964312

MENTOR TONO-PEN 3 by Mentor Ophthalmics, Inc. — Product Code HKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1996
Date Received
October 29, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer, Manual
Device Class
Class II
Regulation Number
886.1930
Review Panel
OP
Submission Type

Other clearances by Mentor Ophthalmics, Inc.

  • K973146 — MENTOR SUPER ABSORBENT DRAPE (December 4, 1997)
  • K971538 — MENTOR GEMINI HEMOSTATIC ERASER (July 14, 1997)
  • K960765 — MENTOR ADVENT A/B SYSTEM (August 8, 1996)

Other clearances for product code HKY

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  • K233516 — Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) (May 1, 2024)
  • K234037 — CATS-L Tonometer™ Prism (February 9, 2024)
  • K232143 — Applanation Tonometer HT-5000 (October 23, 2023)
  • K220852 — iCare IC200 (October 6, 2022)
  • K211355 — iCare HOME2 (January 25, 2022)
  • K203850 — CATS®-D Tonometer Prism (June 14, 2021)
  • K200966 — Icare HOME Tonometer (May 7, 2020)
  • K190316 — Icare ic200 (January 14, 2020)
  • K191314 — Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q (December 19, 2019)