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510(k) K252348

Tomey Optical Biometer OA-2000 (OA-2000) by Tomey Corporation — Product Code MXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2025
Date Received
July 29, 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

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  • K202989 — Myopia Master (July 14, 2021)
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  • K182659 — Galilei G6 Lens Professional (July 25, 2019)
  • K191051 — ARGOS (May 16, 2019)
  • K152311 — Pentacam AXL (January 20, 2016)
  • K150754 — ARGOS (October 2, 2015)