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NEW VUES (TM)(VIFILCON A)(HYDROPHILIC)SOFT LENSES

FDA premarket approval P820021/S023 · decided 1991-08-06

Approval details

PMA number
P820021
Supplement
S023
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
NEW VUES (TM)(VIFILCON A)(HYDROPHILIC)SOFT LENSES
Generic name
Lenses, soft contact, extended wear
Applicant
Alcon Laboratories, Inc.
Date received
1991-04-03
Decision date
1991-08-06
Days to decision
125 days
Decision code
APPR
Product code
LPM
Advisory committee
Ophthalmic
Expedited review
No
Location
Fort Worth, TX

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510(k) clearances by this applicant

RecordFirmDate
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Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal (K233856)Alcon Laboratories, Inc.2023-12-29