K191933 is an FDA 510(k) clearance for the COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal. 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 August 16, 2019, 28 days after receiving the submission on July 19, 2019.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K191933 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2019 |
| Decision Date | August 16, 2019 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQC - Unit, Phacofragmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4670 |