K181401 is an FDA 510(k) clearance for the RxSight Insertion Device. 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 July 26, 2018, 58 days after receiving the submission on May 29, 2018.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4300.
| 510(k) Number | K181401 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2018 |
| Decision Date | July 26, 2018 |
| Days to Decision | 58 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 |