# Kowa Pharmaceuticals America, Inc. (other, Montgomery, AL): 1 new FDA device listing, incl. ophthalmoscope, laser, scanning

**Score:** 50/100

| Field | Value |
|---|---|
| Establishment | Kowa Pharmaceuticals America, Inc. |
| Role | Other |
| Establishment types | Complaint File Establishment per 21 CFR 820.198 |
| Location | Montgomery, AL, US |
| New listings | 1 |
| Devices | Ophthalmoscope, Laser, Scanning |
| Product codes | MYC |
| Device classes | Class II |
| Medical specialties | Ophthalmic |
| Brand names | FM-600 |
| First new listing | 2026-09-16 |
| Latest new listing | 2026-09-16 |
| FDA registration number | 2080939 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.

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: 2026-11-04T21:52:36.524Z.
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.