FDA 510(k)

METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

K-Number: K980218 · 1998-03-23

Decision Date1998-03-23

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR is the device name listed in this FDA 510(k) record. The listed applicant is Biocompatibles Eyewear, Inc.. It received FDA 510(k) clearance on 1998-03-23 under 510(k) number K980218. 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 METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR?

METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR is a medical device that received FDA 510(k) clearance on 1998-03-23. The listed applicant is Biocompatibles Eyewear, Inc.. The 510(k) number is K980218.

When did METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR receive FDA 510(k) clearance?

METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR received FDA 510(k) clearance on 1998-03-23, under 510(k) number K980218.

Who is the listed applicant for METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR?

The FDA 510(k) record lists Biocompatibles Eyewear, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR?

The FDA product code for METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR is LPL.

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Other records listing Biocompatibles Eyewear, Inc. as applicant

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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.