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FDA 510(k)

WESTCON HORIZON 49% (HIOXIFILCON B)

K-Number: K080686 · 2008-04-22

ApplicantWestcon Contact Lens Co.
Decision Date2008-04-22
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

WESTCON HORIZON 49% (HIOXIFILCON B) is the device name listed in this FDA 510(k) record. The listed applicant is Westcon Contact Lens Co.. It received FDA 510(k) clearance on 2008-04-22 under 510(k) number K080686. 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 WESTCON HORIZON 49% (HIOXIFILCON B)?

WESTCON HORIZON 49% (HIOXIFILCON B) is a medical device that received FDA 510(k) clearance on 2008-04-22. The listed applicant is Westcon Contact Lens Co.. The 510(k) number is K080686.

When did WESTCON HORIZON 49% (HIOXIFILCON B) receive FDA 510(k) clearance?

WESTCON HORIZON 49% (HIOXIFILCON B) received FDA 510(k) clearance on 2008-04-22, under 510(k) number K080686.

Who is the listed applicant for WESTCON HORIZON 49% (HIOXIFILCON B)?

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

What is the FDA product code for WESTCON HORIZON 49% (HIOXIFILCON B)?

The FDA product code for WESTCON HORIZON 49% (HIOXIFILCON B) is LPL.

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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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