K192418 is an FDA 510(k) clearance for the Phacoemulsification Needle (Tip) and Irrigation Sleeve. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by Raico, LLC (Westmont, US). The FDA issued a Cleared decision on May 27, 2020, 266 days after receiving the submission on September 4, 2019.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K192418 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2019 |
| Decision Date | May 27, 2020 |
| Days to Decision | 266 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 |