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510(k) K083316

3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM by Topcon Medical Systems, Inc. — Product Code OBO

K083316 is an FDA 510(k) premarket notification submitted by Topcon Medical Systems, Inc. for the device "3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM". The FDA issued a decision of Substantially Equivalent on March 13, 2009. The device falls under product code OBO (Tomography, Optical Coherence), a Class II device regulated under 21 CFR 886.1570. Topcon Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2009
Date Received
November 10, 2008
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 Medical Systems, Inc.

  • K182376 — Harmony (September 28, 2018)
  • K151952 — Synergy ODM (October 1, 2015)
  • K132438 — IMAGENET 5 PC SOFTWARE SYSTEM (October 17, 2013)
  • K132667 — SYNERGY ODM (October 9, 2013)
  • K123101 — TRC-50DX RETINAL CAMERA (June 5, 2013)
  • K123460 — TRC-NW300 NON-MYDRIATIC RETINAL CAMERA (February 6, 2013)
  • K110489 — SLIT LAMP SL-2G (May 23, 2011)
  • K093313 — SYNERGY (December 2, 2009)
  • K072971 — TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINA (January 13, 2009)
  • K031831 — TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM (December 19, 2003)

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