K241398 is an FDA 510(k) clearance for the SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses. This device is classified as a Lens, Contact (other Material) - Daily (Class II - Special Controls, product code HQD).
Submitted by Tianjin Mastervision Technology Co., Ltd. (Tianjin, CN). The FDA issued a Cleared decision on October 22, 2024, 159 days after receiving the submission on May 16, 2024.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5916.
| 510(k) Number | K241398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2024 |
| Decision Date | October 22, 2024 |
| Days to Decision | 159 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQD - Lens, Contact (other Material) - Daily |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5916 |