EYE-CEPT REWETTING DROPS

K041008 · Optics Laboratory, Inc. · LPN · Jul 1, 2005 · Ophthalmic

Device Facts

• Record ID: K041008
• Device Name: EYE-CEPT REWETTING DROPS
• Applicant: Optics Laboratory, Inc.
• Product Code: LPN · Ophthalmic
• Decision Date: Jul 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Use EYE-CEPT® Rewetting Drops while wearing your lenses to moisten and rehydrate them. Also, use EYE-CEPT Rewetting Drops to relieve minor irritation, discomfort and/or blurring which may occur while wearing your lenses.

Device Story

Eye-Cept Rewetting Drops are an ophthalmic solution for use with soft (hydrophilic) contact lenses. The device is applied topically by the patient while wearing lenses to provide moisture, rehydration, and relief from minor irritation, discomfort, or blurring. It functions as a contact lens care product to maintain lens comfort during wear.

Technological Characteristics

Ophthalmic solution for soft (hydrophilic) contact lenses. Product code LPN. Class II device per 21 CFR 886.5928.

Indications for Use

Indicated for contact lens wearers experiencing minor irritation, discomfort, or blurring while wearing lenses; used to moisten and rehydrate lenses during wear.

Regulatory Classification

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.”

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 - 2005

Optics Laboratory Inc. c/o J. R. Chen, Ph.D. Sage Pharmaceuticals Inc. 5408 Interstate Drive Shreveport, LA 71109

Re: K041008

Trade/Device Name: Eye-Cept Rewetting Drops Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN Dated: May 2, 2005 Received: May 5, 2005

Dear Dr. Chen:

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, listing 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 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.

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Page 2 - J. R. Chen, Ph.D.

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 [phone]. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

David M. Whipple

David M. Whipple Acting 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 for Use

510(k) Number (if known):

K041008

Device Name:

Indications For Use:

EYE-CEPT REWETTING DROPS

Use EYE-CEPT® Rewetting Drops while wearing your lenses to moisten and rehydrate them. Also, use EYE-CEPT Rewetting Drops to relieve minor irritation, discomfort and/or blurring which may occur while wearing your lenses.

Page 1 of 1 Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mondell

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Ophinalmic Ea
Nose and Throat Devisess

510(k) Number K041008

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