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FDA 510(k)

PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS

K-Number: K994335 · 2000-03-20

ApplicantWesley Jessen Corp.
Decision Date2000-03-20
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Wesley Jessen Corp.. It received FDA 510(k) clearance on 2000-03-20 under 510(k) number K994335. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS?

PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS is a medical device that received FDA 510(k) clearance on 2000-03-20. The listed applicant is Wesley Jessen Corp.. The 510(k) number is K994335.

When did PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS receive FDA 510(k) clearance?

PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS received FDA 510(k) clearance on 2000-03-20, under 510(k) number K994335.

Who is the listed applicant for PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS?

The FDA 510(k) record lists Wesley Jessen Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS?

The FDA product code for PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS is LPL.

Related Clinical Trials

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Other records listing Wesley Jessen Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K000439DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 2 (PHEMFILCON A) SHERICAL ( HYDROPHILIC)CK993935DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPIK991000GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSESK991550FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENSK982988PRECISION UV (VASURFILCON A)K982344DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONTAC LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPHIS

View all 11 devices →

Related Devices (Code: LPL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd.K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo PlusINTEROJO, Inc.K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact LensesPegavision CorporationK261299Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact LensesPegavision CorporationK253885PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSESGEO MEDICAL CO., LTD.K254269Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact LensSt. shine Optical Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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