FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES
FDA premarket approval P000030 · decided 2001-10-12
Approval details
- PMA number
- P000030
- Trade name
- FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2000-07-18
- Decision date
- 2001-10-12
- Days to decision
- 451 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR THE FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES. THE DEVICE IS INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WITH UP TO APPROXIMATELY 1.50 DIOPTERS OF ASTIGMATISM. THE LENSES MAY BE PRESCRIBED FOR EXTENDED WEAR FOR 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION OR DISPOSAL OF THE LENS, AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. LENSES SHOULD BE REPLACED EVERY MONTH AND
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal (K254052) | Alcon Laboratories, Inc. | 2026-02-13 |
| LenSx Laser System (8065000944) (K252682) | Alcon Laboratories, Inc. | 2025-09-24 |
| LenSx Laser System (8065998162) (K243896) | Alcon Laboratories, Inc. | 2025-04-28 |
| Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric (K243909) | Alcon Laboratories, Inc. | 2025-01-13 |
| 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 |