← Product Code [LYL](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL) · K964222

# ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING (K964222)

_Paladin Medical, Inc. · LYL · Dec 20, 1996 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL/K964222

## Device Facts

- **Applicant:** Paladin Medical, Inc.
- **Product Code:** [LYL](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL.md)
- **Decision Date:** Dec 20, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.5928
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Indications for Use

ACU-CLENS™ Cleaning Accessory is indicated for use with recommended contact lens cleaning solutions for cleaning soft (hydrophilic) and rigid gas permeable contact lenses in accordance with directions for use in the solution labeling. The device aids in cleaning by minimizing hand contact with lenses.

## Device Story

Manual contact lens cleaning accessory; mimics figure-eight hand-in-palm motion. Device consists of durable plastic case with hinge-mounted base, cover, lens receptacles, and mounting posts for disposable foam pads. User applies professionally recommended cleaning solution to pads; places lenses on pads; closes case; moves motion plate in figure-eight pattern to scrub both sides of lenses simultaneously. Intended for patient use at home. Benefits include reduced manual handling of lenses. Disposable pads discarded after each use; case disinfected after each use.

## Clinical Evidence

Bench testing only. Scanning Electron Microscope (SEM) photographs used to evaluate lens cleaning efficacy. Foam pads tested for cytotoxicity and eye irritation; results confirmed non-toxic and non-irritating.

## Technological Characteristics

Mechanical cleaning device; plastic case construction; disposable foam pads. Manual operation via figure-eight motion plate. No energy source or software.

## Regulatory Identification

A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.

## Special Controls

*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

## Predicate Devices

- THE CLEANER™ Accessory by Easy Eyes, Eaton Medical Corporation

## Submission Summary (Full Text)

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K 964222 DEC 20 1996

510(k) Summary DATE SUMMARY REVISED: November 27, 1996

## SUBMITTER:

Submitted on behalf of:
The CLENSER Corporation
Address: 7100 Boyd Avenue
Eden Prairie, MN 55346-3534
Telephone: 612-934-1616

by:
Paladin Medical, Inc.
P. O. Box 560
Stillwater, MN 55082
CONTACT PERSON: Elaine Duncan

**TRADE NAME:** ACU-CLENS™ Cleaning Accessory
**COMMON NAME:** Contact Lens Cleaning Accessory

## SUBSTANTIALLY EQUIVALENT TO: The CLEANER™ Accessory by Easy Eyes, Eaton Medical Corporation

**DESCRIPTION:** ACU-CLENS™ Cleaning Accessory for Contact Lens Cleaning is a method of cleaning contact lenses that mimics the figure-eight hand-in-palm motion. The ACU-CLENS™ Cleaning Accessory can be used with hard (gas permeable) and soft (hydrophilic) lenses. ACU-CLENS™ Cleaning Accessory features a durable plastic case and disposable foam pads for use with professionally recommended daily cleaning solutions. The hinge mounted base and cover contain right and left lens receptacles and four mounting posts which secures the disposable pad to the base. The cover provides a motion plate, cleaning head domes and a hinged latch to secure the disposable pad to the cleaning head domes. Daily cleaning solution (recommended by an eye care professional or physician) is applied to the disposable pad secured to the cleaning head domes and the right and left receptacle and the lenses are placed on the disposable pad above the right and left receptacle. After closing the case the motion plate on the cover is moved in a figure-8 motion to create the scrubbing effect necessary to clean both top and bottom of each lens simultaneously. Lenses should be thoroughly disinfected using solution recommended by physicians or eye-care professionals. The disposable pad should be removed and discarded and the Cleaning Case disinfected after each use.

**INDICATIONS FOR USE:** ACU-CLENS™ Cleaning Accessory is indicated for use with recommended contact lens cleaning solutions for cleaning soft (hydrophilic) and rigid gas permeable contact lenses in accordance with directions for use in the solution labeling. The device aids in cleaning by minimizing hand contact with lenses.

**SUPPORTING INFORMATION:** The ACU-CLENS™ Cleaning Accessory is intended for use with a fresh pad each use, whereas THE CLEANER ACCESSORY™ by Easy Eyes® recommends cleaning and reuse of the pads. The CLENSER Corporation does not recommend reuse of the cleaning pads. Labeling instructions for use of the ACU-CLENS™ Cleaning Accessory state that the cleaning pads should not be reused. Replacement pads are available, sold separately. The foam pads used in the ACU-CLENS™ Cleaning Accessory have been tested for cytotoxicity and eye irritation and have been found to be non-toxic and non-irritating. The ACU-CLENS™ Cleaning Accessory has been designed to minimize the hand contact with lenses normally associated with cleaning instructions accompanying cleaning solutions. The CLENSER Corporation has tested lenses with the ACU-CLENS™ Cleaning Accessory, the results of which are represented by Scanning Electron Microscope photographs.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL/K964222](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL/K964222)

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