K230722 is an FDA 510(k) clearance for the Eagle device. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Belkin Vision, Ltd. (Yavne, IL). The FDA issued a Cleared decision on December 8, 2023, 267 days after receiving the submission on March 16, 2023.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K230722 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 2023 |
| Decision Date | December 08, 2023 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQF - Laser, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4390 |