Submission Details
| 510(k) Number | K023732 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 06, 2002 |
| Decision Date | December 10, 2002 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
K023732 is an FDA 510(k) clearance for the CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Ciba Vision Corporation (Duluth, US). The FDA issued a Cleared decision on December 10, 2002, 34 days after receiving the submission on November 6, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.
| 510(k) Number | K023732 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 06, 2002 |
| Decision Date | December 10, 2002 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LPL — Lenses, Soft Contact, Daily Wear |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5925 |