510(k) K110986
K110986 is an FDA 510(k) premarket notification submitted by Optomed OY for the device "OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1". The FDA issued a decision of Substantially Equivalent on May 16, 2011. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Optomed OY has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 2011
- Date Received
- April 8, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Camera, Ophthalmic, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1120
- Review Panel
- OP
- Submission Type