Home / 510(k) Clearances / K960924

510(k) K960924

KOWA HAND-HELD APPLANATION TONOMETER HA-1 by Kowa Optimed, Inc. — Product Code HKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1996
Date Received
March 6, 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 Kowa Optimed, Inc.

  • K013805 — KOWA AUTOMATED TONOMETER KT-500 (October 11, 2002)
  • K961090 — AUTOMATIC VISUAL FIELD PLOTTER AP-125 (June 17, 1996)
  • K955442 — KOWA SC-1200 PHOTO SLIT LAMP SYSTEM (January 3, 1996)
  • K954780 — KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C (December 1, 1995)
  • K954781 — KOWA GENESIS HAND-HELD FUNDUS CAMERA (December 1, 1995)
  • K954782 — KOWA PORTABLE SLIT LAMP SL-14 & SL-14B (November 24, 1995)
  • K913852 — LASER FLARE METER (February 7, 1992)
  • K880920 — LASER FLARE CELL METER FC-1000 (September 27, 1988)
  • K881219 — AUTOMATIC PERIMETER, AP-340 (May 3, 1988)

Other clearances for product code HKY

  • K241447 — iCare ST500 (TA04) (September 27, 2024)
  • 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)