K210609 is an FDA 510(k) clearance for the AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens. This device is classified as a Lenses, Soft Contact, Daily Wear (Class II - Special Controls, product code LPL).
Submitted by Vp Optics (Daejeon, KR). The FDA issued a Cleared decision on April 27, 2021, 57 days after receiving the submission on March 1, 2021.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5925.
| 510(k) Number | K210609 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2021 |
| Decision Date | April 27, 2021 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LPL - Lenses, Soft Contact, Daily Wear |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5925 |