Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses
FDA 510(k) clearance K221768 · decided 2023-05-05
Clearance details
- K-number
- K221768
- Device name
- Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses
- Applicant
- Paragon Vision Sciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-06-17
- Decision date
- 2023-05-05
- Days to decision
- 322 days
- Clearance type
- Traditional
- Product code
- HQD
- Device class
- 2
- Regulation number
- 886.5916
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Gilbert, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.