PRECISION(TM) UV (VASURFILCON)
FDA premarket approval P940013/S002 · decided 1994-11-09
Approval details
- PMA number
- P940013
- Supplement
- S002
- Supplement type
- THIRTY DAY TRACK
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PRECISION(TM) UV (VASURFILCON)
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 1994-10-06
- Decision date
- 1994-11-09
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
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510(k) clearances by this applicant
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| Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric (K243909) | Alcon Laboratories, Inc. | 2025-01-13 |
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| 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 |