510(k) K261255
K261255 is an FDA 510(k) premarket notification submitted by Kowa Company, Ltd. Chofu Factory for the device "KOWA FM-600". The FDA issued a decision of Substantially Equivalent on September 11, 2026. The device falls under product code MYC (Ophthalmoscope, Laser, Scanning), a Class II device regulated under 21 CFR 886.1570.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2026
- Date Received
- April 16, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ophthalmoscope, Laser, Scanning
- Device Class
- Class II
- Regulation Number
- 886.1570
- Review Panel
- OP
- Submission Type