VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
FDA premarket approval P990085 · decided 2001-02-16
Approval details
- PMA number
- P990085
- Trade name
- VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Johnson & Johnson Vision Care, Inc.
- Date received
- 1999-12-20
- Decision date
- 2001-02-16
- Days to decision
- 424 days
- Decision code
- APWD
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- THE VISTAKON SPHERICAL (LENEFILCON A) CONTACT LENS IS INDICATED FOR DAILY AND EXTENDED WEAR FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN NOT-APHAKIC PERSONS WITH NON-DISEASED EYES. THE LENS IS INDICATED FOR DAILY WEAR IN APHAKIC PERSONS. THE LENS MAY BE WORN BY PERSONS WHO HAVE ASTIGMATISM OF 1.00 DIOPTER OR LESS WHICH DOES NOT INTERFERE WITH VISUAL ACUITY.THE VISTAKON BIFOCAL (LENEFILCON A) CONTACT LENS IS INDICATED FOR DAILY AND EXTENDED WEAR FOR THE CORRECTION OF DISTA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) (K210930) | Johnson & Johnson Vision Care, Inc. | 2021-11-29 |
| ACUVUE (senofilcon A) Soft Contact Lens Multifocal (K200243) | Johnson & Johnson Vision Care, Inc. | 2020-03-17 |
| ACUVUE OASYS (senofilcon A) with Photochromic Additive (K180299) | Johnson & Johnson Vision Care, Inc. | 2018-04-10 |
| ACUVUE (senofilcon C) Soft Contact Lens (K160212) | Johnson & Johnson Vision Care, Inc. | 2016-03-28 |
| ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA (K141670) | Johnson & Johnson Vision Care, Inc. | 2014-09-18 |
| VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER (K100349) | Johnson & Johnson Vision Care, Inc. | 2010-05-21 |
| VISTAKON (NARAFILCON) A SOFT CONTACT LENS (K073485) | Johnson & Johnson Vision Care, Inc. | 2008-03-03 |
| VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) (K062614) | Johnson & Johnson Vision Care, Inc. | 2006-11-01 |