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FDA 510(k)

SEE3 (LOTRAFILCON A) SOFT CONTACT LENS

K-Number: K970746 · 1997-05-09

ApplicantCiba Vision Corporation
Decision Date1997-05-09
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SEE3 (LOTRAFILCON A) SOFT CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Ciba Vision Corporation. It received FDA 510(k) clearance on 1997-05-09 under 510(k) number K970746. 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 SEE3 (LOTRAFILCON A) SOFT CONTACT LENS?

SEE3 (LOTRAFILCON A) SOFT CONTACT LENS is a medical device that received FDA 510(k) clearance on 1997-05-09. The listed applicant is Ciba Vision Corporation. The 510(k) number is K970746.

When did SEE3 (LOTRAFILCON A) SOFT CONTACT LENS receive FDA 510(k) clearance?

SEE3 (LOTRAFILCON A) SOFT CONTACT LENS received FDA 510(k) clearance on 1997-05-09, under 510(k) number K970746.

Who is the listed applicant for SEE3 (LOTRAFILCON A) SOFT CONTACT LENS?

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

What is the FDA product code for SEE3 (LOTRAFILCON A) SOFT CONTACT LENS?

The FDA product code for SEE3 (LOTRAFILCON A) SOFT CONTACT LENS is LPL.

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Other records listing Ciba Vision Corporation 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.

K123994DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCALK113168DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORICK083216CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSESK073459CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSESK072777CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSESK062262CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS

View all 43 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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