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Eyerisol

by Bionomics Intl., Inc.

PMA P810034

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 P810034↗

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 NumberP810034 Date28 May 1985ApprovedStatusActive

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  • Withdrawn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
Eyerisol(R)
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

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.

Eyerisol is a soft lens accessory designed for ophthalmic use, classified under the nomenclature for accessories intended to support contact lens care and handling. It serves as a protective and storage solution for soft contact lenses, ensuring they remain clean and hydrated between use.

This device is supplied as a reusable accessory, intended for use in clinical and home settings. It is regulated under FDA Premarket Approval (PMA) with the classification of Class II (PMA Number: P810034). The product adheres to regulatory standards outlined in 21 CFR 886.5928 and is intended for ophthalmic applications, with no specific sterility or MRI safety requirements noted in the data.

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 primary purpose of the Eyerisol® device in clinical or home settings?

    The Eyerisol® is designed as a reusable accessory to protect and store soft contact lenses, ensuring they remain clean and hydrated between uses. It is specifically intended for ophthalmic applications, supporting proper contact lens care and handling in both clinical and home environments.

  • Is the Eyerisol® device single-use or reusable, and how does this affect its use?

    The Eyerisol® is explicitly labeled as a reusable accessory, meaning it is intended for repeated use over time. This design allows for consistent lens care in both clinical and home settings, though proper cleaning and maintenance are required to uphold its functionality and hygiene.

  • What regulatory pathway does the Eyerisol® follow, and what does this mean for its use?

    The Eyerisol® is regulated under FDA Premarket Approval (PMA) as a Class II device (PMA Number: P810034), adhering to 21 CFR 886.5928. This means it has undergone rigorous review to ensure safety and effectiveness for its intended ophthalmic use as a soft lens accessory, though it does not require specific sterility or MRI safety documentation in the available data.

  • Are there different sizes or models of the Eyerisol®, and if so, how might they vary?

    The provided data does not specify distinct sizes or models of the Eyerisol® beyond its classification as a reusable soft lens accessory. However, its design is standardized for general ophthalmic use, ensuring compatibility with most soft contact lenses while maintaining a single-purpose function: protection and hydration during storage.