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LenSoak

by Abbott Medical Optics, Inc.

PMA P790023

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 P790023↗

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 NumberP790023 Date3 Mar 1982ApprovedStatusActive

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  • Withdrawn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
Accessories, soft lens products
PMA Number
FDA Product Code
LPN
Device Class
Class II
Regulation
21 CFR Part 886.5928
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved
PMA Supplement
S001

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.

LenSoak is a soft lens product accessory designed for the cleaning and storage of soft contact lenses. According to the nomenclature authority classification, it falls under the category of Accessories, Soft Lens Products, intended to maintain lens hygiene and integrity between use.

This device is supplied as a single-use solution and is regulated under FDA Premarket Approval (PMA) with PMA number P790023. It is intended for use in ophthalmic settings, adhering to regulatory standards outlined in regulation number 886.5928. The solution is packaged for individual use and must be stored according to manufacturer guidelines to ensure sterility and effectiveness.

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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.

  • Is LenSoak intended for reuse or is it a single-use solution for cleaning and storing soft contact lenses?

    LenSoak is designed as a single-use solution for cleaning and storing soft contact lenses. Each package is meant for one-time use to maintain lens hygiene and integrity between wear, ensuring optimal safety and effectiveness.

  • How should LenSoak be stored to maintain its sterility and effectiveness?

    LenSoak must be stored according to the manufacturer’s guidelines to preserve sterility and performance. Since it is a single-use solution, it should be kept in its original, unopened packaging until ready for use, away from direct sunlight, extreme temperatures, and contamination.

  • What regulatory pathway does LenSoak follow, and what does this mean for its use?

    LenSoak is regulated under FDA Premarket Approval (PMA) with PMA number P790023, indicating it has undergone rigorous review for safety and effectiveness. This approval ensures it meets stringent standards for maintaining soft contact lens hygiene in ophthalmic settings, as classified under Accessories, Soft Lens Products (product code LPN).

  • Are there different sizes or models of LenSoak, or is it a standardized solution for all soft contact lenses?

    LenSoak is supplied as a standardized single-use solution and is not differentiated by sizes or models. It is intended for general use with soft contact lenses, adhering to the same cleaning and storage protocols regardless of lens type or brand.