VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY)
FDA 510(k) clearance K062614 · decided 2006-11-01
Clearance details
- K-number
- K062614
- Device name
- VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY)
- Applicant
- Johnson & Johnson Vision Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-09-05
- Decision date
- 2006-11-01
- Days to decision
- 57 days
- Clearance type
- Special
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Jacksonville, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses. The Vistakon (eta recall (Z-1335-2013) | Johnson & Johnson Vision Care, Inc. | 2013-05-17 |
| ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact lenses. The recall (Z-1336-2013) | Johnson & Johnson Vision Care, Inc. | 2013-05-17 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LENEFILCON A HYDROPHILIC CONTACT LENSES (P990085/S001) | Johnson & Johnson Vision Care, Inc. | 2001-09-19 |
| VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (P990085) | Johnson & Johnson Vision Care, Inc. | 2001-02-16 |