K812126 is an FDA 510(k) clearance for the ULTRASONIC TIPS. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on September 18, 1981, 53 days after receiving the submission on July 27, 1981.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K812126 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 1981 |
| Decision Date | September 18, 1981 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HQC — Unit, Phacofragmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4670 |