510(k) K093313
K093313 is an FDA 510(k) premarket notification submitted by Topcon Medical Systems, Inc. for the device "SYNERGY". The FDA issued a decision of Substantially Equivalent on Dec 2, 2009. The device falls under product code NFJ (System, Image Management, Ophthalmic), a Class II device regulated under 21 CFR 892.2050. Topcon Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 2, 2009
- Date Received
- Oct 22, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Image Management, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- OP
- Submission Type