Submission Details
| 510(k) Number | K191795 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 03, 2019 |
| Decision Date | July 31, 2019 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Special
AOCup Lens Case with AODisc
Jul 2019
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K191795 is an FDA 510(k) clearance for the AOCup Lens Case with AODisc, 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 July 31, 2019, 28 days after receiving the submission on July 3, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.
Device Classification
| Product Code | LPN — Accessories, Soft Lens Products |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5928 |
Manufacturer
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