KOWA FM-600— 510(k) K261255
Substantially EquivalentKowa Company, Ltd. Chofu Factory
FDA 510(k) clearance K261255 for KOWA FM-600, Substantially Equivalent on 2026-09-11. Applicant: Kowa Company, Ltd. Chofu Factory. Device class: 2.
Summary
The KOWA FM-600 is filed under MYC, scanning laser ophthalmoscopes. The record doesn't describe its imaging modes.
Class II, 21 CFR 886.1570. The Ophthalmic panel reviewed it as a Traditional 510(k).
The applicant is Kowa's Chofu Factory, filing from Tokyo, Japan. Review took 148 days (April 16 to September 11, 2026).
Clearance details
- Applicant
- Kowa Company, Ltd. Chofu Factory
- Product code
- Product code MYC
- Device class
- Class 2
- Regulation
- 21 CFR 886.1570
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, JP
Recent devices under product code MYC
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