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510(k) K232143

Applanation Tonometer HT-5000 by Huvitz Co., Ltd. — Product Code HKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2023
Date Received
July 19, 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 Huvitz Co., Ltd.

  • K202097 — Fundus Camera (February 2, 2021)
  • K191615 — Huvitz Imaging System (July 18, 2019)
  • K161829 — Huvitz Imaging System (April 6, 2017)
  • K093639 — SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 (December 3, 2009)
  • K073190 — SLIT LAMP (January 11, 2008)

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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)
  • 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)