K231123 is an FDA 510(k) clearance for the Phoenix Contact Lens Case - dome top flat pack (CL-01). This device is classified as a Case, Contact Lens (Class II - Special Controls, product code LRX).
Submitted by Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. (Navi Mumbai, IN). The FDA issued a Cleared decision on August 30, 2023, 132 days after receiving the submission on April 20, 2023.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K231123 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 2023 |
| Decision Date | August 30, 2023 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LRX - Case, Contact Lens |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5928 |