K210396 is an FDA 510(k) clearance for the Harmony Referral System. This device is classified as a System, Image Management, Ophthalmic (Class II - Special Controls, product code NFJ).
Submitted by Topcon Healthcare Solutions EMEA Oy (Oulu, FI). The FDA issued a Cleared decision on September 13, 2021, 215 days after receiving the submission on February 10, 2021.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K210396 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2021 |
| Decision Date | September 13, 2021 |
| Days to Decision | 215 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | NFJ - System, Image Management, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |