PRECISION(TM) UV (VASURFILCON)
FDA premarket approval P940013/S005 · decided 1996-10-07
Approval details
- PMA number
- P940013
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PRECISION(TM) UV (VASURFILCON)
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 1996-04-04
- Decision date
- 1996-10-07
- Days to decision
- 186 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR THE TINTING OF THE DEVICE WITH AN ALTERNATE, NON-REACTIVE, LIGHT BLUE-GREEN LOCATOR TINT (D&C GREEN NO. 6, C.I. NO. 61565) USING AN IN-MONOMER TINTING PROCESS FOR THE PRECISION(TM) UN (VASURFILCON A) HYDROPHILIC CONTACT LENS FOR EXTENDED WEAR
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510(k) clearances by this applicant
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|---|---|---|
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| 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 |