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510(k) K213265

Tomey Cornea/Anterior Segment OCT CASIA2 by Tomey Corporation — Product Code OBO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2022
Date Received
September 30, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tomography, Optical Coherence
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.

Other clearances by Tomey Corporation

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  • K171313 — EM-4000 Specular Microscope (January 19, 2018)
  • K073087 — NON-CONTACT TONOMETER, MODEL FT-1000 (November 18, 2008)

Other clearances for product code OBO

  • K252633 — UNITY DX (UDX) (December 23, 2025)
  • K250553 — Tomey Cornea/Anterior Segment OCT (CASIA2) (July 18, 2025)
  • K250868 — SPECTRALIS HRA+OCT and variants (May 12, 2025)
  • K240924 — Anterion (December 13, 2024)
  • K241163 — SPECTRALIS with Flex Module (October 11, 2024)
  • K241081 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic (July 17, 2024)
  • K240221 — SPECTRALIS HRA+OCT and variants (July 1, 2024)
  • K233933 — CIRRUS™ HD-OCT Model 6000 (May 17, 2024)
  • K233602 — P200TE (A10700) (May 9, 2024)
  • K233561 — 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) (April 10, 2024)