Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)
FDA 510(k) clearance K233325 · decided 2024-02-21
Clearance details
- 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
- Decision
- Substantially Equivalent
- Date received
- 2023-09-29
- Decision date
- 2024-02-21
- Days to decision
- 145 days
- Clearance type
- Traditional
- Product code
- HQD
- Device class
- 2
- Regulation number
- 886.5916
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Front Royal, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.