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FDA 510(k)

VISTAKON (HEFILCON C) CONTACT LENSES

K-Number: K010218 · 2001-03-16

ApplicantVistakon
Decision Date2001-03-16
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VISTAKON (HEFILCON C) CONTACT LENSES is the device name listed in this FDA 510(k) record. The listed applicant is Vistakon. It received FDA 510(k) clearance on 2001-03-16 under 510(k) number K010218. 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 VISTAKON (HEFILCON C) CONTACT LENSES?

VISTAKON (HEFILCON C) CONTACT LENSES is a medical device that received FDA 510(k) clearance on 2001-03-16. The listed applicant is Vistakon. The 510(k) number is K010218.

When did VISTAKON (HEFILCON C) CONTACT LENSES receive FDA 510(k) clearance?

VISTAKON (HEFILCON C) CONTACT LENSES received FDA 510(k) clearance on 2001-03-16, under 510(k) number K010218.

Who is the listed applicant for VISTAKON (HEFILCON C) CONTACT LENSES?

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

What is the FDA product code for VISTAKON (HEFILCON C) CONTACT LENSES?

The FDA product code for VISTAKON (HEFILCON C) CONTACT LENSES is LPL.

Related Clinical Trials

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.

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Other records listing Vistakon 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.

K042275VISTAKON (SENOFILCON A) SOFT CONTACT LENSK033969ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKERK013973ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOCK010507VISTAKON (METHAFILCON A) CONTACT LENSES

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

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

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