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HYDRON SEMI SCLERAL, MINI, TORIC

FDA premarket approval P780007/S001 · decided 1979-12-17

Approval details

PMA number
P780007
Supplement
S001
Supplement type
Normal 180 Day Track
Trade name
HYDRON SEMI SCLERAL, MINI, TORIC
Generic name
Lenses, soft contact, daily wear
Applicant
CooperVision, Inc.
Date received
1979-09-27
Decision date
1979-12-17
Days to decision
81 days
Decision code
APPR
Product code
LPL
Advisory committee
Ophthalmic
Expedited review
No
Location
Fairport, NY

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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