Submission Details
| 510(k) Number | K173538 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
Dec 2017
Decision
19d
Days
Class 2
Risk
About This 510(k) Submission
K173538 is an FDA 510(k) clearance for the Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc, 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 review panel. Regulated under 21 CFR 886.5928.
Device Classification
| Product Code | LRX — Case, Contact Lens |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5928 |
Manufacturer
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