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. These image the retina with a scanning laser instead of a conventional flash fundus camera. 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 in Tokyo. Kowa has made fundus cameras and other ophthalmic diagnostics for decades. At 148 days (April 16 to September 11, 2026), the review ran about as long as retinal imaging hardware normally does.
Clearance details
- Applicant
- Kowa Company, Ltd. Chofu Factory
- Product code
- 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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