Harmony

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 Harmony.

Pre-market Notification Details

• Device ID: K182376
• 510k Number: K182376
• Device Name: Harmony
• Classification: System, Image Management, Ophthalmic
• Applicant: Topcon Medical Systems, Inc. 111 Bauer Drive Oakland, NJ 07436
• Contact: James Lorkowski
• Correspondent: Maureen O'connell; O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864
• Product Code: NFJ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-08-31
• Decision Date: 2018-09-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850003069043	K182376	000
00850003069296	K182376	000
00850003069289	K182376	000
00850003069128	K182376	000
00850003069234	K182376	000
00850003069227	K182376	000
00850003069197	K182376	000
00850003069111	K182376	000
00850003069180	K182376	000
00850003069173	K182376	000
00850003069012	K182376	000
00850003069098	K182376	000
00850003069265	K182376	000