FDA 510(k)

GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS

K-Number: K962711 · 1996-09-05

Decision Date1996-09-05

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Gelflex Laboratories. It received FDA 510(k) clearance on 1996-09-05 under 510(k) number K962711. 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 GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS?

GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS is a medical device that received FDA 510(k) clearance on 1996-09-05. The listed applicant is Gelflex Laboratories. The 510(k) number is K962711.

When did GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS receive FDA 510(k) clearance?

GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS received FDA 510(k) clearance on 1996-09-05, under 510(k) number K962711.

Who is the listed applicant for GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS?

The FDA 510(k) record lists Gelflex Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS?

The FDA product code for GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS is LPL.

Related Clinical Trials

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Other records listing Gelflex Laboratories as applicant

K181558Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens K030027GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%K962710GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS

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.