K173538 is an FDA 510(k) clearance for the Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc. This device is classified as a Case, Contact Lens (Class II - Special Controls, product code LRX).
Submitted by Alcon Laboratories, Inc. (Fort Worth, US). The FDA issued a Cleared decision on December 4, 2017, 19 days after receiving the submission on November 15, 2017.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K173538 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2017 |
| Decision Date | December 04, 2017 |
| Days to Decision | 19 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LRX — Case, Contact Lens |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5928 |