SYNERGY

System, Image Management, Ophthalmic

TOPCON MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Topcon Medical Systems, Inc. with the FDA for Synergy.

Pre-market Notification Details

• Device ID: K093313
• 510k Number: K093313
• Device Name: SYNERGY
• Classification: System, Image Management, Ophthalmic
• Applicant: TOPCON MEDICAL SYSTEMS, INC. 5 TIMBER LANE North Reading, MA 01864
• Contact: Maureen O'connell
• Correspondent: Tamas Borsai; TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470
• Product Code: NFJ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2009-10-22
• Decision Date: 2009-12-02
• Summary: summary