K221263 is an FDA 510(k) clearance for the Aqua Naina Plus 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 October 12, 2022, 163 days after receiving the submission on May 2, 2022.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K221263 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2022 |
| Decision Date | October 12, 2022 |
| Days to Decision | 163 days |
| Submission Type | Special |
| 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 |