PRECISION(TM) UV (VASURFILCON)
FDA premarket approval P940013 · decided 1994-09-30
Approval details
- PMA number
- P940013
- Trade name
- PRECISION(TM) UV (VASURFILCON)
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 1994-05-06
- Decision date
- 1994-09-30
- Days to decision
- 147 days
- Decision code
- APWD
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- FOR THE PRECISION (IV' (VASURFILCON A) HYDROPHILIC CONTACTLENS FOR EXTENDED WEAR. THIS DEVICE IS INDICATED FOR NON-APHAKIC DAILY OREXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING, RINSING, ANDDISINFECTING, AS RECOMMENDED BY THE EYE CARE PRACTITIONER. CANDIDATES TO USETHE PRECISION UV'" HYDROPHILIC CONTACT LENS INCLUDE PERSONS WHO ARE NEARSIGHTED(MYOPIC) AND FARSIGHTED (HYPEROPIC) AND WHO MAY HAVE ASTIGMATISM OF 2.0DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.
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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 |