K182659 is an FDA 510(k) clearance for the Galilei G6 Lens Professional. This device is classified as a Device, Analysis, Anterior Segment (Class II - Special Controls, product code MXK).
Submitted by Sis Ag, Surgical Instrument Systems (Port, CH). The FDA issued a Cleared decision on July 25, 2019, 303 days after receiving the submission on September 25, 2018.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850.
| 510(k) Number | K182659 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2018 |
| Decision Date | July 25, 2019 |
| Days to Decision | 303 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MXK - Device, Analysis, Anterior Segment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1850 |