The ACUVUE® 2 COLOURS Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.

The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or not-aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.

The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with nondiseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.

The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) TORIC-BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or not-aphakic persons with non-diseased who may have 10.00 D of astigmatism or less.

ACUVUE® 2 COLOURS UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The ACUVUE 2 COLOURS Contact Lenses may be prescribed for daily wear. Eye Care Practitioners may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement (see "Wearing Schedule"). When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.

Device Description

The device description is identical to that cleared under K010114.

AI/ML Overview

The provided document is a 510(k) summary for a contact lens, ACUVUE® 2 COLOURS™ Brand (etafilcon A) soft (hydrophilic) contact lenses with UV blocker. It is a submission for substantial equivalence to a previously cleared device (K010114) and does not contain a study proving the device meets specific acceptance criteria.

Instead, it states that:

The device description, intended use, and technological characteristics are identical to the predicate device.
Non-clinical tests were conducted as recommended by the Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, revised May 1994, and are included in PMA N18-033/S038. These tests include:
- Toxicology Testing
- Cytotoxicity
- USP Ocular Irritation
- USP Systemic Injection
- Leachable Monomer and Additive
- Physical/Chemical Testing
- Stability Testing
Clinical data is not required for this submission.

Therefore, I cannot provide the information requested in your prompt as it pertains to a study demonstrating specific device performance against acceptance criteria. The document is a regulatory submission for substantial equivalence based on the device being identical to an already approved device and non-clinical testing.

Summary

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K024177

JAN 2 2 2003

510(k) Summary

Name andAddress ofSubmitter	VISTAKON®, Division of Johnson & Johnson Vision Care, Inc.7500 Centurion Parkway, Suite 100Jacksonville, Florida 32256Contact: James W. ParzialePhone: (904) 443-1808Date Prepared: December 12, 2002
Identification ofDevice	Trade Name: ACUVUE® 2 COLOURS™ Brand (etafilcon A) soft (hydrophilic) contact lenses with UV blocker Common or Usual Name: Soft (hydrophilic) Contact Lens (daily wear) Classification: Class II under 21 CFR 886.5925
PredicateDevices	The predicate devices is the:ACUVUE® 2 COLOURS™ Brand (etafilcon A) soft (hydrophilic) contact lenses with UV blocker cleared under K010114 on April 11, 2001.
DeviceDescription	The device description is identical to that cleared under K010114.
Intended Use	The intended use is identical to that cleared under K010114.
TechnologicalCharacteristics	The technological characteristics are identical to that cleared under K010114.
	Continued on next page

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510(k) Summary, Continued

Non-ClinicalStudies	The following tests were conducted as recommended by the PremarketNotification 510(k) Guidance Document for Daily Wear Contact Lenses,revised May 1994 and are included in PMA N18-033/S038.• Toxicology Testing• Cytotoxicity• USP Ocular Irritation• USP Systemic Injection• Leachable Monomer and Additive• Physical/Chemical Testing• Stability Testing
Clinical Studies	Clinical data is not required for this submission.
Conclusions	The ACUVUE® 2 COLOURS™ Brand (etafilcon A) soft (hydrophilic)contact lenses with UV blocker, which is the subject of this 510(k), issubstantially equivalent to the ACUVUE® 2 COLOURS™ Brand (etafilconA) soft (hydrophilic) contact lenses with UV blocker, cleared under 510(k)K010114 on April 11, 2001.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that suggest a profile view.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 2003

Mr. James W. Parziale Project Leader, Regulatory and Clinical Affairs VISTAKON, Division of Johnson-Johnson Vision Care, Inc. 7500 Centurion Parkway, Suite 100 Jacksonville, FL 32256

Re: K024177

Trade/Device Name: ACUVUE® 2 COLOURS™ Brand (etafilcon A) Soft (hydrophilic) Contact Lenses with UV Blocker Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL; MVN Dated: December 17, 2002 Received: December 18, 2002

Dear Mr. Parziale:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. James W. Parziale

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications Statement

510(k) Number (if known):

Device Name:

ACUVUE® 2 COLOURS™ Brand (etafilcon A) soft (hydrophilic) contact lenses with UV blocker

Indications for Use:

ACUVUE® 2 COLOURS UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓	OR	Over the Counter
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(Division Sign-Off)

Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number	K024177
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CONFIDENTIAL

Regulation Number and Section

§ 886.5925 Soft (hydrophilic) contact lens.

(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.