K223132 is an FDA 510(k) clearance for the Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models). This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Iridex Corporation (Mountain View, US). The FDA issued a Cleared decision on November 9, 2022, 37 days after receiving the submission on October 3, 2022.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K223132 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2022 |
| Decision Date | November 09, 2022 |
| Days to Decision | 37 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQF - Laser, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4390 |