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Wet-N-Soak Rewetting Drops

by Advanced Medical Optics, Inc.

PMA P900047

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P900047↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP900047 Date5 Apr 1994ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Full name
Wet-N-Soak(Tm) Rewetting Drops
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
S002 (Normal 180 Day Track)

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 Wet-N-Soak Rewetting Drops are a sterile ophthalmic accessory designed for soft contact lenses. Classified under the nomenclature for accessories, soft lens products, these drops are intended to maintain lens hydration and comfort during wear.

Supplied as single-use units, these drops are regulated under FDA PMA (P900047) and fall under device class II. They are intended for use in ophthalmic settings and comply with regulation number 886.5928. Each unit is sterile and packaged for individual application, ensuring proper lens care and maintenance.

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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 Wet-N-Soak Rewetting Drops?

    The Wet-N-Soak Rewetting Drops are designed to maintain hydration and comfort for soft contact lenses during wear. They serve as an ophthalmic accessory to enhance lens comfort.

  • How are the Wet-N-Soak Rewetting Drops supplied?

    The drops are supplied as single-use units, each packaged for individual application. This ensures proper lens care and maintenance with each use.

  • Are the Wet-N-Soak Rewetting Drops sterile?

    Yes, each unit of Wet-N-Soak Rewetting Drops is sterile and packaged for individual application to maintain proper hygiene for contact lens users.

  • What is the regulatory classification of Wet-N-Soak Rewetting Drops?

    The drops are classified under device class II and regulated under FDA PMA (P900047), with regulation number 886.5928 for ophthalmic accessories.