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510(k) K201724

Pentacam AXL Wave by Oculus Optikgerate GmbH — Product Code MXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2020
Date Received
June 23, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Analysis, Anterior Segment
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type

Other clearances by Oculus Optikgerate GmbH

  • K152311 — Pentacam AXL (January 20, 2016)
  • K113066 — CORVIS ST (November 8, 2012)
  • K073508 — PARKONE (September 11, 2008)
  • K041841 — PACHYCAM (January 28, 2005)
  • K030719 — PENTACAM SCHEIMPFLUG CAMERA (September 16, 2003)

Other clearances for product code MXK

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  • K252348 — Tomey Optical Biometer OA-2000 (OA-2000) (December 18, 2025)
  • K223700 — BOSS™ (August 16, 2024)
  • K222933 — MYAH (June 29, 2023)
  • K211868 — MYAH (March 1, 2022)
  • K202989 — Myopia Master (July 14, 2021)
  • K182659 — Galilei G6 Lens Professional (July 25, 2019)
  • K191051 — ARGOS (May 16, 2019)
  • K152311 — Pentacam AXL (January 20, 2016)
  • K150754 — ARGOS (October 2, 2015)