K121405 is an FDA 510(k) clearance for the PANOPTIC. This device is classified as a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on December 20, 2012, 224 days after receiving the submission on May 10, 2012.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1120.
| 510(k) Number | K121405 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 2012 |
| Decision Date | December 20, 2012 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HKI — Camera, Ophthalmic, Ac-powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.1120 |