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Easy Eyes

by Eaton Medical Corp.

PMA P830009

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 P830009↗

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 NumberP830009 Date23 Apr 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  • Withdrawn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
Easy Eyes (Tm)
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
S006

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.

Easy Eyes is a soft lens accessory designed for ophthalmic use. It falls under the category of accessories for soft contact lenses, intended to assist in lens handling, insertion, or removal during eye care procedures.

The device is supplied as a reusable accessory and is regulated under FDA Premarket Approval (PMA) with the classification of Class II. It is intended for use in clinical settings and must be maintained in accordance with manufacturer guidelines to ensure sterility and functionality. The product is authorized under PMA number P830009 and is associated with the product code LPN.

Other devices from Eaton Medical Corp.

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 Easy Eyes™ device in clinical ophthalmology settings?

    The Easy Eyes™ is designed as a reusable accessory specifically for soft contact lenses, intended to simplify lens handling, insertion, or removal during eye care procedures. It aids clinicians in managing lenses more efficiently while maintaining patient comfort and precision.

  • Is the Easy Eyes™ device single-use or reusable, and how should it be maintained?

    The Easy Eyes™ is explicitly described as a reusable accessory. To ensure sterility and functionality, it must be maintained according to the manufacturer’s guidelines, which likely include cleaning, disinfection, and proper storage protocols to prevent contamination or damage.

  • What regulatory pathway does the Easy Eyes™ follow, and what does this mean for its use?

    The Easy Eyes™ is authorized under FDA Premarket Approval (PMA) with PMA number P830009, classifying it as a Class II device. This means it has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended use as an accessory for soft contact lenses in clinical settings.

  • Are there different sizes or models of the Easy Eyes™, and how would I identify the correct one for my practice?

    The provided data does not specify distinct sizes or models of the Easy Eyes™, but it is associated with multiple FEI numbers and registration numbers under the product code LPN. If your practice requires specific adaptations, you may need to confirm compatibility with Eaton Medical Corp. or refer to their technical documentation, as variations may exist for different lens types or clinical workflows.