K193441 is an FDA 510(k) clearance for the Aqua Naina Sterile Saline Solution. This device is classified as a Accessories, Soft Lens Products (Class II - Special Controls, product code LPN).
Submitted by Chemtex USA, Inc. (Fairfield, US). The FDA issued a Cleared decision on May 26, 2020, 167 days after receiving the submission on December 11, 2019.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K193441 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2019 |
| Decision Date | May 26, 2020 |
| Days to Decision | 167 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 |