FDA 510(k)

GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS

K-Number: K011072 · 2001-08-24

Decision Date2001-08-24

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Gelflex. It received FDA 510(k) clearance on 2001-08-24 under 510(k) number K011072. 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 TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS?

GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS is a medical device that received FDA 510(k) clearance on 2001-08-24. The listed applicant is Gelflex. The 510(k) number is K011072.

When did GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS receive FDA 510(k) clearance?

GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS received FDA 510(k) clearance on 2001-08-24, under 510(k) number K011072.

Who is the listed applicant for GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS?

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

What is the FDA product code for GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS?

The FDA product code for GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS is LPL.

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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.