FDA 510(k)

CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS

K-Number: K033919 · 2004-03-12

Decision Date2004-03-12

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS 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 2004-03-12 under 510(k) number K033919. 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 CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS?

CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS is a medical device that received FDA 510(k) clearance on 2004-03-12. The listed applicant is Ciba Vision Corporation. The 510(k) number is K033919.

When did CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS receive FDA 510(k) clearance?

CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS received FDA 510(k) clearance on 2004-03-12, under 510(k) number K033919.

Who is the listed applicant for CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS?

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 CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS?

The FDA product code for CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS is LPL.

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Other records listing Ciba Vision Corporation as applicant

K123994DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL K113168DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC K083216CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES K073459CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES K072777CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES K062262CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS

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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.