K152046 is an FDA 510(k) clearance for the Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A). This device is classified as a Lenses, Soft Contact, Daily Wear (Class II - Special Controls, product code LPL).
Submitted by Art Optical Contact Lens, Inc. (Walker, US). The FDA issued a Cleared decision on November 24, 2015, 124 days after receiving the submission on July 23, 2015.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5925.
| 510(k) Number | K152046 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2015 |
| Decision Date | November 24, 2015 |
| Days to Decision | 124 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 |