K253822
- 510(k) number
- K253822
- Device name
- GPA (hexafocon A) Rigid Gas Permeable Contact Lenses
- Applicant
- Zhuhai Fitlens Medical Technology Co., Ltd. CN
- Product code
- HQD — Lens, Contact (Other Material) - Daily
- Decision date
- 2026-03-27
- Date received
- 2025-11-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253822.pdf
Official FDA record: K253822
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.