K201909 is an FDA 510(k) clearance for the RxSight Contact Lens. This device is classified as a Lens, Contact, Polymethylmethacrylate, Diagnostic (Class II - Special Controls, product code HJK).
Submitted by Rxsight, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on September 10, 2020, 63 days after receiving the submission on July 9, 2020.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1385.
| 510(k) Number | K201909 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2020 |
| Decision Date | September 10, 2020 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HJK - Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1385 |