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TETRAFILCON A

FDA premarket approval N17679 · decided 1976-06-18

Approval details

PMA number
N17679
Trade name
TETRAFILCON A
Generic name
Lenses, soft contact, extended wear
Applicant
CooperVision, Inc.
Date received
1975-01-01
Decision date
1976-06-18
Days to decision
534 days
Decision code
APPR
Product code
LPM
Advisory committee
Ophthalmic
Expedited review
No
Location
Pleasanton, CA

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510(k) clearances by this applicant

RecordFirmDate
Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker (K234127)CooperVision, Inc.2024-01-25
MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens (K220070)CooperVision, Inc.2022-02-04
Avaira Vitality (K213164)CooperVision, Inc.2021-10-26
Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) (K202756)CooperVision, Inc.2020-10-20
MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC (K191763)CooperVision, Inc.2020-03-23
MyDay (K190965)CooperVision, Inc.2019-04-29
Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker (K181920)CooperVision, Inc.2018-12-11
Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens (K160803)CooperVision, Inc.2016-07-13