K013232 is an FDA 510(k) clearance for the CYBERCASES BY BAUSCH & LOMB. This device is classified as a Case, Contact Lens (Class II - Special Controls, product code LRX).
Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on November 20, 2001, 54 days after receiving the submission on September 27, 2001.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K013232 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2001 |
| Decision Date | November 20, 2001 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LRX - Case, Contact Lens |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5928 |