FDA 510(k)

FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN

K-Number: K020139 · 2002-04-09

Decision Date2002-04-09

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN 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 2002-04-09 under 510(k) number K020139. 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 FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN?

FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN is a medical device that received FDA 510(k) clearance on 2002-04-09. The listed applicant is Ciba Vision Corporation. The 510(k) number is K020139.

When did FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN receive FDA 510(k) clearance?

FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN received FDA 510(k) clearance on 2002-04-09, under 510(k) number K020139.

Who is the listed applicant for FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN?

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 FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN?

The FDA product code for FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN 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.