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510(k) K190382

Intraocular Pressure Tonometer EASYTON by Company Elamed — Product Code HKX

K190382 is an FDA 510(k) premarket notification submitted by Company Elamed for the device "Intraocular Pressure Tonometer EASYTON". The FDA issued a decision of Substantially Equivalent on December 6, 2019. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2019
Date Received
February 19, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer, Ac-Powered
Device Class
Class II
Regulation Number
886.1930
Review Panel
OP
Submission Type

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  • K223739 — VS Tabletop Tonometer (November 8, 2023)
  • K181260 — MiiS Horus Scope DPT 100 (June 21, 2019)
  • K181143 — Keeler TonoCare Tonometer (February 8, 2019)
  • K180820 — Tono Vue Non-Contact Tonometer (December 14, 2018)
  • K162067 — VX130 Ophthalmic Diagnostic Device (April 24, 2017)
  • K143086 — VX120 Ophthalmic Diagnostic Device (June 1, 2015)
  • K113066 — CORVIS ST (November 8, 2012)
  • K111710 — FULL AUTO TONOMETER MODEL TX-20 (September 20, 2011)
  • K093298 — PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 (December 10, 2010)

FDA data resources