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510(k) K113066

CORVIS ST by Oculus Optikgerate GmbH — Product Code HKX

K113066 is an FDA 510(k) premarket notification submitted by Oculus Optikgerate GmbH for the device "CORVIS ST". The FDA issued a decision of Substantially Equivalent on November 8, 2012. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930. Oculus Optikgerate GmbH has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2012
Date Received
October 17, 2011
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

Other clearances by Oculus Optikgerate GmbH

  • K201724 — Pentacam AXL Wave (October 21, 2020)
  • K152311 — Pentacam AXL (January 20, 2016)
  • K073508 — PARKONE (September 11, 2008)
  • K041841 — PACHYCAM (January 28, 2005)
  • K030719 — PENTACAM SCHEIMPFLUG CAMERA (September 16, 2003)

Other clearances for product code HKX

  • K253039 — AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA (November 7, 2025)
  • K223739 — VS Tabletop Tonometer (November 8, 2023)
  • K190382 — Intraocular Pressure Tonometer EASYTON (December 6, 2019)
  • 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)
  • 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