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C-65 Daily Contact Lens Cleaner

by Advanced Medical Optics, Inc.

PMA P790024

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 P790024↗

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 NumberP790024 Date29 Nov 1984ApprovedStatusActive

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  • Withdrawn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

Trade Name
Lc-65 Daily Contact Lens Cleaner
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

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.

This device is a Contact Lens Cleaner, classified under accessories for soft contact lenses. It is designed to clean and maintain daily-wear soft contact lenses by removing debris, proteins, and deposits to ensure proper hygiene and lens clarity.

The C-65 Daily Contact Lens Cleaner is intended for home use and is supplied as a single-use solution. It is regulated under FDA PMA (Premarket Approval) as a Class II device (product code LPN) and complies with regulation 886.5928. The solution is non-sterile and must be stored in a cool, dry place away from direct sunlight.

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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 C-65 Daily Contact Lens Cleaner intended for and how does it work?

    The C-65 Daily Contact Lens Cleaner is designed specifically for home use to clean and maintain daily-wear soft contact lenses. It removes debris, proteins, and deposits to ensure proper hygiene and lens clarity, helping to keep lenses clean and comfortable for wearers.

  • Is the C-65 Daily Contact Lens Cleaner single-use or reusable, and what are its storage requirements?

    The C-65 Daily Contact Lens Cleaner is supplied as a single-use solution, meaning each bottle is intended for one-time use. Since it is non-sterile, it must be stored in a cool, dry place away from direct sunlight to maintain its effectiveness and safety.

  • What regulatory pathway does the C-65 Daily Contact Lens Cleaner follow, and what class is it assigned?

    The C-65 Daily Contact Lens Cleaner is regulated under the FDA’s Premarket Approval (PMA) pathway as a Class II device, classified under product code LPN (Accessories for Soft Contact Lenses). This classification aligns with its role as an accessory for maintaining soft contact lens hygiene.

  • Are there multiple versions or sizes of the C-65 Daily Contact Lens Cleaner, and how would I identify the correct one?

    The C-65 Daily Contact Lens Cleaner is listed under multiple FEI (Final Establishment Identification) numbers, indicating it may have been distributed under various lot or batch identifiers, but there is no indication of differing sizes or models in the provided data. The trade name remains consistent as LC-65, so verifying the label or packaging ensures you have the correct product.