K974281 is an FDA 510(k) clearance for the ALCON CONTACT LENS CASE. This device is classified as a Case, Contact Lens (Class II - Special Controls, product code LRX).
Submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on January 20, 1998, 67 days after receiving the submission on November 14, 1997.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K974281 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 1997 |
| Decision Date | January 20, 1998 |
| Days to Decision | 67 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 |