ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR
FDA 510(k) clearance K051900 · decided 2005-08-12
Clearance details
- K-number
- K051900
- Device name
- ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR
- Applicant
- Johnson & Johnson Vision Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-07-13
- Decision date
- 2005-08-12
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- MVN
- 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 |
|---|---|---|
| Outer Carton labeled in part:" 1-DAY ACUVUE MOIST BRAND CONTACT LENSES WITH LACREON FOR AS recall (Z-0734-2012) | Johnson & Johnson Vision Care, Inc. | 2012-01-12 |
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 |