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Gelflex Delta 55 (Methafilcon A) Hydrophilic Contact Lens

by Gelflex Laboratories

510(k) K962710

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK962710 Date5 Sep 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LPL
Device Class
Class II
Regulation
21 CFR Part 886.5925
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a soft, hydrophilic contact lens made from methafilcon A, a material known for its water-retaining properties. It is designed to provide comfort and clear vision for individuals with refractive errors such as myopia or hyperopia.

The lens is indicated for daily wear in aphakic and non-aphakic persons with nondisease conditions. It is supplied as a single-use device and has received FDA 510(k) clearance under product code LPL and regulation number 886.5925, with a decision of substantially equivalent (SESE) dated September 5, 1996.

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