K142284 is an FDA 510(k) clearance for the CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE. This device is classified as a Accessories, Soft Lens Products (Class II - Special Controls, product code LPN).
Submitted by Alcon Laboratories, Inc. (Fort Worth, US). The FDA issued a Cleared decision on January 26, 2015, 161 days after receiving the submission on August 18, 2014.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K142284 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2014 |
| Decision Date | January 26, 2015 |
| Days to Decision | 161 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 |