510(k) K201325
K201325 is an FDA 510(k) premarket notification submitted by Optomed Oyj for the device "Optomed Smartscope M5 with Optomed Smartscope FA". The FDA issued a decision of Substantially Equivalent on November 20, 2020. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Optomed Oyj has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 2020
- Date Received
- May 18, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Ophthalmic, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1120
- Review Panel
- OP
- Submission Type