LENEFILCON A HYDROPHILIC CONTACT LENSES
FDA premarket approval P990085/S001 · decided 2001-09-19
Approval details
- PMA number
- P990085
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LENEFILCON A HYDROPHILIC CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Johnson & Johnson Vision Care, Inc.
- Date received
- 2001-08-23
- Decision date
- 2001-09-19
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR AN ALTERNATE PACKAGE INTEGRITY TEST METHOD TO SUPPORT SHELF-LIFE AND ASSIGN EXPIRATION DATES IN LIEU OF STERILITY TESTING.
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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 |