DURASOFT(R) 3 FOR EXT WEAR
FDA premarket approval P830037 · decided 1984-04-24
Approval details
- PMA number
- P830037
- Trade name
- DURASOFT(R) 3 FOR EXT WEAR
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 1983-07-07
- Decision date
- 1984-04-24
- Days to decision
- 292 days
- Decision code
- APWD
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR THE DURASOFT 3 (PHEMFILCON A) EXTENDED WEAR HYDROPHILIC CONTACT LENS. THE LENS IS INDICATED FOR UP TO 14 DAYS OF CONTINUOUS WEAR BETWEEN CLEANING AND DISINFECTION (EXTENDED WEAR) BY PERSONS WITH EYES THAT ARE NON-DISEASED, NOT-APHAKIC, HAVE NO MORE THAN 2.00 DIOPTERS (D) OF ASTIGMATISM, AND REQUIRE A SPHERICAL LENS IN THE POWER RANGE FROM -20.00 D TO +0.00 D FOR THE CORRECTION OF NEARSIGHTEDNESS (MYOPIA) OR FARSIGHTEDNESS (HYPEROPIA). THE LENS IS TO BE DISINFECTED USING EITHER A HEA
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |