K233325
- 510(k) number
- K233325
- Device name
- Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)
- Applicant
- Visionary Optics, LLC VA · US
- Product code
- HQD — Lens, Contact (Other Material) - Daily
- Decision date
- 2024-02-21
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233325.pdf
Official FDA record: K233325
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.