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510(k) K233561

3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) by Topcon Corporation — Product Code OBO

K233561 is an FDA 510(k) premarket notification submitted by Topcon Corporation for the device "3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))". The FDA issued a decision of Substantially Equivalent on April 10, 2024. The device falls under product code OBO (Tomography, Optical Coherence), a Class II device regulated under 21 CFR 886.1570. Topcon Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2024
Date Received
November 6, 2023
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 Topcon Corporation

  • K253039 — AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA (November 7, 2025)
  • K241081 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic (July 17, 2024)
  • K232828 — IMAGEnet6 Ophthalmic Data System (March 1, 2024)
  • K231222 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) (October 30, 2023)
  • K221111 — Non-Mydriatic Retinal Camera NW500 (August 29, 2022)
  • K173119 — DRI OCT Triton (January 19, 2018)
  • K171370 — IMAGEnet 6 Ophthalmic Data System (November 1, 2017)
  • K170164 — 3D OCT-1 Maestro (March 3, 2017)
  • K161972 — Slit Lamp SL-D301 (December 9, 2016)
  • K161509 — 3D OCT-1 Maestro (July 28, 2016)

Other clearances for product code OBO

  • K253837 — SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module (May 7, 2026)
  • 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)

FDA data resources