K231838 is an FDA 510(k) clearance for the RxSight® Insertion Device (63002). This device is classified as a Folders And Injectors, Intraocular Lens (iol) (Class I - General Controls, product code MSS).
Submitted by Rxsight, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on August 15, 2023, 54 days after receiving the submission on June 22, 2023.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4300.
| 510(k) Number | K231838 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2023 |
| Decision Date | August 15, 2023 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MSS - Folders And Injectors, Intraocular Lens (iol) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4300 |