510(k) K151952
K151952 is an FDA 510(k) premarket notification submitted by Topcon Medical Systems, Inc. for the device "Synergy ODM". The FDA issued a decision of Substantially Equivalent on October 1, 2015. 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
- October 1, 2015
- Date Received
- July 15, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Management, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- OP
- Submission Type