K200747 is an FDA 510(k) clearance for the PuriLens Plus Preservative Free Saline. This device is classified as a Accessories, Soft Lens Products (Class II - Special Controls, product code LPN).
Submitted by The Lifestyle Company, Inc. (Freehold, US). The FDA issued a Cleared decision on May 15, 2020, 53 days after receiving the submission on March 23, 2020.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K200747 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 2020 |
| Decision Date | May 15, 2020 |
| Days to Decision | 53 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 |