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Tri Pol 43 Contact Lens

by Gbf Contact Lenses, Inc.

PMA P780013

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P780013↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP780013 Date19 Jun 1980ApprovedStatusActive

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  • Withdrawn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 PMA Active

Specification

PMA

Generic Name
Lenses, soft contact, daily wear
PMA Number
FDA Product Code
LPL
Device Class
Class II
Regulation
21 CFR Part 886.5925
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved
PMA Supplement
S002

Overview

AI-generated summary, 18 Sep 2026

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

The Tri Pol 43 Contact Lens is a soft contact lens designed for daily wear, intended to correct refractive errors and improve visual acuity. These lenses are classified as a Class II medical device under FDA regulations and fall under the nomenclature of soft contact lenses, providing a non-surgical vision correction solution for patients.

These lenses are supplied as single-use, non-sterile devices and are regulated under FDA Premarket Approval (PMA) with PMA number P780013. They are intended for ophthalmic use and must be handled and stored according to manufacturer guidelines to ensure proper fit and hygiene. The device is authorized for distribution in the United States and adheres to regulatory standards outlined in 21 CFR Part 886, Subpart B, under product code LPL.

Questions

AI-generated answers, 18 Sep 2026

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

  • Are these contact lenses intended for overnight wear or only daily use?

    The Tri Pol 43 Contact Lens is explicitly designed for daily wear only, as stated in the device description. It is not intended for extended or overnight use, which requires specialized lenses with additional safety features.

  • How should these lenses be stored before use, and are they sterile?

    The Tri Pol 43 Contact Lenses are supplied as non-sterile and intended for single-use. They must be stored according to the manufacturer’s guidelines to maintain hygiene and integrity, though no specific storage conditions (e.g., refrigeration, humidity) are detailed in the provided data.

  • What regulatory pathway was followed for FDA approval, and what does this mean for purchasing in the U.S.?

    The Tri Pol 43 Contact Lens received FDA Premarket Approval (PMA) under PMA number P780013, indicating a rigorous review process for Class II devices. This approval ensures compliance with 21 CFR Part 886, Subpart B, product code LPL, and authorizes distribution only in the United States. Purchasers should confirm the device’s PMA status and registration numbers match their intended use.

  • Are there multiple sizes or models available for this contact lens, or is it a single prescription type?

    The provided data does not specify individual sizes or base curves, but the generic name (