VISTAKON (SENOFILCON A) SOFT CONTACT LENS
FDA 510(k) clearance K042275 · decided 2004-10-28
Clearance details
- K-number
- K042275
- Device name
- VISTAKON (SENOFILCON A) SOFT CONTACT LENS
- Applicant
- Vistakon
- Decision
- Substantially Equivalent
- Date received
- 2004-08-23
- Decision date
- 2004-10-28
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Tampa, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, recall (Z-1131-2019) | Johnson & Johnson Vision Care, Inc. | 2019-04-11 |