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Permatint Soft Contact Lenses

by Wesley Jessen Corp.

PMA P820059

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 P820059↗

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 NumberP820059 Date10 Dec 1984ApprovedStatusActive

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  • Withdrawn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
Permatint(R)
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.

Permatint Soft Contact Lenses are classified as Lenses, Soft Contact, Daily Wear, designed for ophthalmic use. These lenses are intended to correct vision and may be used for cosmetic purposes, providing a comfortable and clear visual experience for daily wear.

These lenses are supplied in sterile, single-use packaging and are regulated under FDA_PMA with PMA number P820059. They are intended for use in clinical settings by trained professionals and are available in multiple registration numbers and product codes, including LPL. No MRI safety or reusable specifications are indicated in the data.

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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.

  • Are these contact lenses reusable or intended for single-use only?

    Permatint Soft Contact Lenses are supplied in sterile, single-use packaging, meaning each lens is designed for one-time wear only. This ensures hygiene and reduces the risk of infection, aligning with daily-wear contact lens standards.

  • What types of vision correction or cosmetic purposes can these lenses address?

    Permatint Soft Contact Lenses are classified as daily-wear soft contact lenses and are intended to correct vision. They may also be used for cosmetic purposes, such as altering eye appearance, while providing a comfortable and clear visual experience.

  • How are these lenses regulated, and what does that mean for clinical use?

    Permatint Soft Contact Lenses are regulated under an FDA Premarket Approval (PMA) with PMA number P820059. This means they have undergone rigorous review to ensure safety and effectiveness for ophthalmic use, and they are intended for clinical settings by trained professionals only.

  • Are there multiple sizes or models available for these contact lenses?

    Yes, Permatint Soft Contact Lenses are available in multiple registration numbers and product codes, indicating a variety of sizes and models to accommodate different prescription needs and eye measurements. These variations ensure a fit tailored to individual patients.

  • How should these lenses be stored before use, and what are the packaging specifications?

    Permatint Soft Contact Lenses are supplied in sterile, single-use packaging, which means they should be stored in their original, unopened packaging until ready for use. The sterile packaging ensures the lenses remain uncontaminated and safe for one-time wear.