K240095 is an FDA 510(k) clearance for the CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6). This device is classified as a Case, Contact Lens (Class II - Special Controls, product code LRX).
Submitted by Shanghai Care US Medical Product Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on October 9, 2024, 271 days after receiving the submission on January 12, 2024.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K240095 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 2024 |
| Decision Date | October 09, 2024 |
| Days to Decision | 271 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 |