Frequency 55 UV (Methafilcon a) Soft (Hydrophlic) Contact Lens for Daily Wear

FDA 510(k) K020392 · CooperVision, Inc.

Substantially Equivalent

510(k) numberK020392

Submission

Device name
Frequency 55 UV (Methafilcon a) Soft (Hydrophlic) Contact Lens for Daily Wear
Applicant
CooperVision, Inc.
Scottsville,, NY, US
Received
February 6, 2002
Decision date
April 26, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LPL – Lenses, Soft Contact, Daily Wear
Device class
Class II (moderate risk)
Regulation
21 CFR 886.5925
Specialty
Ophthalmic

Other 510(k)s with product code LPL

510(k)DeviceApplicantDecision
K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo…LPL · Traditional INTEROJO, Inc.05/29/2026SE
K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…LPL · Traditional Pegavision Corporation05/21/2026SE
K261299Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…LPL · Special Pegavision Corporation05/19/2026SE
K253885PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON…LPL · Traditional Geo Medical Co., Ltd.04/29/2026SE
K254269Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens…LPL · Traditional St. shine Optical Co., Ltd.03/19/2026SE
K252385Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…LPL · Traditional Pegavision Corporation03/13/2026SE
K254052DAILIES TOTAL1®; DAILIES TOTAL1® MultifocalLPL · Traditional Alcon Laboratories, Inc.02/13/2026SE
K251683Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking…LPL · Traditional Bruno Vision Care, LLC12/23/2025SE
K250364Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens…LPL · Traditional St. shine Optical Co., Ltd.10/07/2025SE
K244009Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily…LPL · Traditional Yung Sheng Optical Co., Ltd.09/25/2025SE

More from Yung Sheng Optical Co., Ltd.

510(k)DeviceDecision
K234127Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact…LPL · Special 01/25/2024SE
K220070MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality…LPL · Special 02/04/2022SE
K213164Avaira VitalityLPL · Special 10/26/2021SE
K202756Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day…LPL · Special 10/20/2020SE
K191763MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A)…LPL · Traditional 03/23/2020SE
K190965MyDayLPL · Special 04/29/2019SE
K181920Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV…LPL · Traditional 12/11/2018SE
K160803Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact LensLPL · Traditional 07/13/2016SE
K133627Avaira Spheric and Toric (Enfilcon a) Soft Contact LensLPL · Special 12/23/2013SE
K131378Sus (Stenfilcon a) Contact LensLPL · Traditional 08/30/2013SE

Questions and answers

When was Frequency 55 UV (Methafilcon a) Soft (Hydrophlic) Contact Lens for Daily Wear cleared by the FDA?

Frequency 55 UV (Methafilcon a) Soft (Hydrophlic) Contact Lens for Daily Wear (K020392) received a 510(k) decision of Substantially Equivalent on April 26, 2002, 79 days after the submission was received.

What is the product code of K020392?

The FDA product code is LPL – Lenses, Soft Contact, Daily Wear, a Class II (moderate risk) device regulated under 21 CFR 886.5925.