Submission Details
| 510(k) Number | K981151 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 30, 1998 |
| Decision Date | June 22, 1998 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
K981151 is an FDA 510(k) clearance for the OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER/ALCON WETTING, SOAKING, CONDITIONING AND DISINFECTING SOLUTION ID 84392, 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 June 22, 1998, 84 days after receiving the submission on March 30, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K981151 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 30, 1998 |
| Decision Date | June 22, 1998 |
| Days to Decision | 84 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 |