FDA 510(k)

GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%

K-Number: K030027 · 2003-04-01

Decision Date2003-04-01

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49% is the device name listed in this FDA 510(k) record. The listed applicant is Gelflex Laboratories. It received FDA 510(k) clearance on 2003-04-01 under 510(k) number K030027. 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 SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%?

GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49% is a medical device that received FDA 510(k) clearance on 2003-04-01. The listed applicant is Gelflex Laboratories. The 510(k) number is K030027.

When did GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49% receive FDA 510(k) clearance?

GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49% received FDA 510(k) clearance on 2003-04-01, under 510(k) number K030027.

Who is the listed applicant for GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%?

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 SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%?

The FDA product code for GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49% is LPL.

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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 K962710GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS K962711GELFLEX ALPHA (POLYMACON) 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.