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510(k) K152311

Pentacam AXL by Oculus Optikgerate GmbH — Product Code MXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2016
Date Received
August 14, 2015
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

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  • K073508 — PARKONE (September 11, 2008)
  • K041841 — PACHYCAM (January 28, 2005)
  • K030719 — PENTACAM SCHEIMPFLUG CAMERA (September 16, 2003)

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  • K182659 — Galilei G6 Lens Professional (July 25, 2019)
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  • K150754 — ARGOS (October 2, 2015)