FDA 510(k)

EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS

K-Number: K082880 · 2009-06-16

Decision Date2009-06-16

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is I-See Vision Technology, Inc.. It received FDA 510(k) clearance on 2009-06-16 under 510(k) number K082880. 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 EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS?

EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS is a medical device that received FDA 510(k) clearance on 2009-06-16. The listed applicant is I-See Vision Technology, Inc.. The 510(k) number is K082880.

When did EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS receive FDA 510(k) clearance?

EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS received FDA 510(k) clearance on 2009-06-16, under 510(k) number K082880.

Who is the listed applicant for EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS?

The FDA 510(k) record lists I-See Vision Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS?

The FDA product code for EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS is LPL.

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Other records listing I-See Vision Technology, Inc. as applicant

K082879EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR K082883EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR

Related Devices (Code: LPL)

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.