K203060 is an FDA 510(k) clearance for the VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by Johnson & Johnson Surgical Vision, Inc. (Santa Ana, US). The FDA issued a Cleared decision on March 12, 2021, 155 days after receiving the submission on October 8, 2020.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K203060 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 08, 2020 |
| Decision Date | March 12, 2021 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQC - Unit, Phacofragmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4670 |