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RGP Daily Cleaning Tablet

by Advanced Medical Optics, Inc.

PMA P880053

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 P880053↗

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 NumberP880053 Date21 May 1992ApprovedStatusActive

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  • Withdrawn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

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
S007 (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 RGP Daily Cleaning Tablet is a cleaning accessory designed for soft lens products, specifically intended for daily maintenance of rigid gas permeable (RGP) contact lenses. It falls under the classification of accessories for soft lens care and is classified as a Class II medical device under FDA regulations.

This tablet is supplied as a single-use item for cleaning RGP lenses and is not sterile. It is regulated under the FDA’s Premarket Approval (PMA) process, with the product authorized under PMA number P880053. The device is intended for use in an ophthalmic setting and adheres to the regulatory requirements outlined in 21 CFR 886.5928.

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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 RGP Daily Cleaning Tablet specifically designed for, and how does it differ from cleaning solutions for soft lenses?

    The RGP Daily Cleaning Tablet is designed exclusively for daily maintenance of rigid gas permeable (RGP) contact lenses, not soft lenses. While it falls under the broader category of accessories for soft lens products in regulatory records, its intended use is limited to cleaning and disinfecting RGP lenses. Unlike liquid cleaning solutions, this tablet provides a convenient, single-use method for lens care without requiring additional containers or dilution steps.

  • Is the RGP Daily Cleaning Tablet sterile, and how should it be stored to maintain its effectiveness?

    The RGP Daily Cleaning Tablet is not sterile and is intended for single-use only. To preserve its efficacy, it should be stored in a cool, dry place away from direct sunlight and moisture. Avoid exposure to extreme temperatures, as this could compromise the tablet’s chemical composition and cleaning properties. Always check the packaging for expiration dates before use.

  • How do I know which size or model of the RGP Daily Cleaning Tablet is compatible with my RGP lenses?

    The RGP Daily Cleaning Tablet is a single-use, standardized product and does not come in multiple sizes or models—it is designed to work universally for all RGP lenses. However, compatibility depends on the manufacturer’s instructions for your specific lens type. Always refer to your lens care guide or consult an eye care professional to confirm proper use, as some RGP materials may require additional precautions.

  • What regulatory pathway was followed for the RGP Daily Cleaning Tablet, and what does that mean for its safety and approval?

    The RGP Daily Cleaning Tablet was authorized through the FDA’s Premarket Approval (PMA) process, specifically under PMA number P880053. This rigorous review ensures the device meets strict safety and effectiveness standards for Class II medical devices. The approval confirms that the tablet has been evaluated for its intended use in maintaining RGP lenses, adhering to FDA regulations under 21 CFR 886.5928.

  • Can the RGP Daily Cleaning Tablet be reused, or is it meant for one-time use only?

    The RGP Daily Cleaning Tablet is explicitly designed for single-use only. Reusing the tablet could lead to contamination, reduced efficacy, or potential damage to the lens. Each tablet is formulated to provide a fresh cleaning and disinfecting cycle, ensuring optimal hygiene for daily RGP lens care. Discard the tablet after one use and replace it with a new one for subsequent cleanings.