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FLUOROPERM RGP CONTACT LENSES

FDA premarket approval P870024 · decided 1987-12-31

Approval details

PMA number
P870024
Trade name
FLUOROPERM RGP CONTACT LENSES
Generic name
Lens, contact (rigid gas permeable), extended wear
Applicant
CooperVision, Inc.
Date received
1987-05-20
Decision date
1987-12-31
Days to decision
225 days
Decision code
APPR
Product code
MWL
Advisory committee
Ophthalmic
Expedited review
No
Location
San Ramon, 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