FDA 510(k)

FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS

K-Number: K971164 · 1997-05-21

Decision Date1997-05-21

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Aspect Vision Care, Ltd.. It received FDA 510(k) clearance on 1997-05-21 under 510(k) number K971164. 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 FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS?

FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS is a medical device that received FDA 510(k) clearance on 1997-05-21. The listed applicant is Aspect Vision Care, Ltd.. The 510(k) number is K971164.

When did FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS receive FDA 510(k) clearance?

FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS received FDA 510(k) clearance on 1997-05-21, under 510(k) number K971164.

Who is the listed applicant for FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS?

The FDA 510(k) record lists Aspect Vision Care, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS?

The FDA product code for FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS is LPL.

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Other records listing Aspect Vision Care, Ltd. as applicant

K982997FREQUENCY 55 UV (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED WITH UV BLOCKER)K980634FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)K973063FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR K971049FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)

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.