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TriPol 43 Soft Contact Lenses

by Wesley Jessen Corp.

PMA N18180

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 N18180

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 NumberN18180 Date11 May 1981ApprovedStatusActive

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  • Withdrawn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

Full name
Tripol 43
Trade Name
Customflex (Deltafilcon a) Hydrophilic Contact Len
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
S003

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 TriPol 43 Soft Contact Lenses are classified as Lenses, Soft Contact, Daily Wear, designed for ophthalmic use. These lenses are intended to correct refractive errors and provide clear, comfortable vision for daily wear by patients. Their construction allows for extended wear while maintaining ocular health and comfort.

These lenses are supplied as single-use or reusable, depending on the specific registration number, and are regulated under FDA_PMA with approval number N18180. They are classified under device class 2 and fall under the regulation 886.5925. The lenses are intended for sterile use and must be handled according to ophthalmic best practices. Multiple registration numbers (e.g., 3015533540, 3012546757) indicate variations in design or prescription, ensuring compatibility with diverse patient needs.

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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.

  • What is the purpose of the TriPol 43 Soft Contact Lenses?

    The TriPol 43 Soft Contact Lenses are designed for ophthalmic use to correct refractive errors and provide clear, comfortable vision for daily wear by patients.

  • Are the TriPol 43 lenses single-use or reusable?

    These lenses are supplied as either single-use or reusable depending on the specific registration number, with multiple registration numbers indicating variations in design or prescription.

  • How should the TriPol 43 lenses be handled and stored?

    The lenses are intended for sterile use and must be handled according to ophthalmic best practices, though specific storage requirements are not detailed in the provided information.

  • What is the regulatory status of the TriPol 43 lenses?

    The lenses are regulated under FDA_PMA with approval number N18180 and are classified under device class 2 with regulation number 886.5925.