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510(k) K023838

LUNEAU STERILE TONOMETER SEPARATION PRISMS by Luneau SA — Product Code HKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2003
Date Received
November 18, 2002
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 Luneau SA

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  • K022413 — LUNEAU 3 MIRROR LENS (September 24, 2002)
  • K851557 — ANESTHESIOMETER (May 30, 1985)

Other clearances for product code HKY

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  • 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)