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510(k) K251848

Pentacam® Cornea OCT by Oculus Optikgeräte GmbH — Product Code MXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2026
Date Received
June 16, 2025
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 Optikgeräte GmbH

  • K202989 — Myopia Master (July 14, 2021)

Other clearances for product code MXK

  • 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)
  • K201724 — Pentacam AXL Wave (October 21, 2020)
  • K182659 — Galilei G6 Lens Professional (July 25, 2019)
  • K191051 — ARGOS (May 16, 2019)
  • K152311 — Pentacam AXL (January 20, 2016)
  • K150754 — ARGOS (October 2, 2015)