K253822 is an FDA 510(k) clearance for the GPA (hexafocon 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 Zhuhai Fitlens Medical Technology Co., Ltd. (Zhuhai, CN). The FDA issued a Cleared decision on March 27, 2026, 119 days after receiving the submission on November 28, 2025.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5916.
| 510(k) Number | K253822 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 2025 |
| Decision Date | March 27, 2026 |
| Days to Decision | 119 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 |