AIR OPTIX PLUS HYDRAGLYDE; AIR OPTIX PLUS HYDRAGLYDE FOR ASTIGMATISM; AIR OPTIX PLUS HYDRAGLYDE MULTIFOCAL; AIR OPTIX PL
FDA premarket approval P010019/S050 · decided 2016-07-19
Approval details
- PMA number
- P010019
- Supplement
- S050
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AIR OPTIX PLUS HYDRAGLYDE; AIR OPTIX PLUS HYDRAGLYDE FOR ASTIGMATISM; AIR OPTIX PLUS HYDRAGLYDE MULTIFOCAL; AIR OPTIX PL
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2016-04-22
- Decision date
- 2016-07-19
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for the addition of 0.04% (400ppm) polyoxyethylene-poluoxybutylene copolymer (EO45BO10) to the package saline for lotrafilcon B silicone hydrogel soft contact lenses for extended wear.
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510(k) clearances by this applicant
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| Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); (K242184) | Alcon Laboratories, Inc. | 2024-12-04 |
| UNITY VCS (8065000296); UNITY CS (8065000297) (K233876) | Alcon Laboratories, Inc. | 2024-06-21 |
| Centurion™ Vision System (Active Sentry™) (8065753057) (K233902) | Alcon Laboratories, Inc. | 2024-01-10 |
| Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal (K233856) | Alcon Laboratories, Inc. | 2023-12-29 |