Home / 510(k) Clearances / K233516

510(k) K233516

Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) by Reichert, Inc. — Product Code HKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2024
Date Received
November 1, 2023
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 Reichert, Inc.

  • K141954 — XCEL 455 SLIT LAMP (October 15, 2014)
  • K081756 — OCULAR RESPONSE ANALYZER (August 7, 2008)
  • K071839 — SOCT COPERNICUS, MODEL 15205 (February 27, 2008)
  • K070534 — MODIFICATION TO: OCU-FILM TIP COVER (March 27, 2007)
  • K063750 — XCEL 255 SLIT LAMP (December 20, 2006)
  • K061330 — PSL PORTABLE SLIT LAMP (May 25, 2006)
  • K042831 — ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER) (October 28, 2004)
  • K032799 — NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER (January 20, 2004)

Other clearances for product code HKY

  • K241447 — iCare ST500 (TA04) (September 27, 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)
  • K182491 — Applanation tonometer AT-2 (December 10, 2018)