Submission Details
| 510(k) Number | K984573 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 23, 1998 |
| Decision Date | September 16, 1999 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
K984573 is an FDA 510(k) clearance for the OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on September 16, 1999, 267 days after receiving the submission on December 23, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K984573 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 23, 1998 |
| Decision Date | September 16, 1999 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LPN — Accessories, Soft Lens Products |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5928 |