Arca
Skip to content

Topcon Corporation

Medical device makerAI in JapanAI. FDA records under 2 spellings of its name, each linked to the record.

  • Records across the group: 52, 6 entitiesAI
  • 510(k) clearances: 47
  • Device recalls: 5

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Topcon Corporation and its 5 subsidiaries

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Sep 18, 2026SLIT LAMP SL-D4 (Type: LED)K262637 · HJO510(k) clearances
Jun 4, 2026Harmony Referral System with Harmony OCT Viewer (Octave)K253893 · NFJ510(k) clearances
Nov 7, 2025AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIAK253039 · HKX510(k) clearances
Jul 17, 20243D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data SystemK241081 · OBO510(k) clearances
Apr 10, 20243D Optical Coherence Tomography (3D OCT-1(type: Maestro2))K233561 · OBO510(k) clearances
Mar 1, 2024IMAGEnet6 Ophthalmic Data SystemK232828 · NFJ510(k) clearances
Nov 20, 2023HarmonyK232555 · NFJ510(k) clearances
Oct 30, 20233D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)K231222 · OBO510(k) clearances
Jul 15, 2016Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conClass II · Topcon discovered an anomaly with titration, only when EpM is turned on during the titration process. This event may ocDevice recalls
Mar 27, 2012PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.Class II · When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and thDevice recalls

Subsidiaries and Divisions

5 firms in the Topcon Corporation group, most records first

Canada and Imports

Across the Topcon Corporation group, matched by company name
Active Health Canada device licences
25, as of Nov 10, 2026
FDA import refusals since 2024
1 shipment lines, through Oct 23, 2026

Names and Identifiers

Appears as
Topcon CorporationTopcon Corp.

Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.