# Topcon Corp. (specification developer, Tokyo, JP): 2 new FDA device listings, incl. camera, ophthalmic, slit-scanning

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Topcon Corp. |
| Owner / operator | Topcon Healthcare, Inc. |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | Tokyo, JP |
| New listings | 2 |
| Devices | Camera, Ophthalmic, Slit-Scanning; Biomicroscope, Slit-Lamp, Ac-Powered |
| Product codes | QER, HJO |
| Device classes | Class II |
| Medical specialties | Ophthalmic |
| Brand names | GAIA; SL-D4 (Type: LED) |
| First new listing | 2026-09-10 |
| Latest new listing | 2026-09-25 |
| FDA registration number | 9614661 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.