K182523 is an FDA 510(k) clearance for the Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens. This device is classified as a Lenses, Soft Contact, Daily Wear (Class II - Special Controls, product code LPL).
Submitted by Largan Medical Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on November 1, 2018, 49 days after receiving the submission on September 13, 2018.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5925.
| 510(k) Number | K182523 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 2018 |
| Decision Date | November 01, 2018 |
| Days to Decision | 49 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 |