HYDRO2, HS-75

K011914 · Innovision, Inc. · HQD · Jul 27, 2001 · Ophthalmic

Device Facts

• Record ID: K011914
• Device Name: HYDRO2, HS-75
• Applicant: Innovision, Inc.
• Product Code: HQD · Ophthalmic
• Decision Date: Jul 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Indications for Use

The bifocal/multifocal designs of the HYDRO2 (filofocon A) contact lens are indicated for daily wear correction of visual acuity in non-aphakic persons with non-diseased presbyopic eyes that are myopic or hyperopic. The lens may be disinfected with chemical disinfection only.

Device Story

Bifocal/Multifocal HYDRO2 (filofocon A) is a rigid gas permeable (RGP) contact lens designed for daily wear. It corrects visual acuity in presbyopic patients. The lens is intended for prescription use only and requires chemical disinfection. It functions as a standard refractive contact lens to improve vision in myopic or hyperopic individuals.

Technological Characteristics

Material: filofocon A. Type: Rigid Gas Permeable (RGP) contact lens. Design: Bifocal/Multifocal. Usage: Daily wear. Disinfection: Chemical only.

Indications for Use

Indicated for daily wear correction of visual acuity in non-aphakic, non-diseased presbyopic patients who are myopic or hyperopic.

Regulatory Classification

Identification

A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is enclosed in a circle with the text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES" around the perimeter of the circle.

JUL 2 7 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

c/o Mr. Don M. Woodford Vice President Innovision, Inc. 3125 South 61st. Ave. Omaha, NE 68106

Re: K011914

K011711
Trade Name: Bifocal/Multifocal HYDRO2 (filofocon A) Daily Wear RGP Contact Lens Regulation Number: 21 CFR 886.5916 Regulatory Class: Class II Product Code: HQD Dated: June 14, 2001 Received: June 19, 2001

Dear Mr. Woodford:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your becally a substantially equivalent (for the indications for use above and we have acterimled in interstate commerce prior to May 28, 1976, the stated in the enotical Device Amendments, or to devices that have been reclassified in encordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, accordance with the provinents siect to the general controls provisions of the Act. The general cherelots, mainor are are are as a contrements for annual registration, listing of devices, eone on provisions or noveling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good 079. I subtained - oguirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may oublish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Don M. Woodford

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] 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

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510(k) Number K011914

## Bifocal/Multifocal HYDRO2 (filofocon A) DEVICE NAME Daily Wear RGP Contact Lens

## INDICATIONS FOR USE

The bifocal/multifocal designs of the HYDRO2 (filofocon A) contact lens are indicated for daily wear correction of visual acuity in non-aphakic persons with non-diseased presbyopic eyes that are myopic or hyperopic. The lens may be disinfected with chemical disinfection only.

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

Prescription Use X

OR Over-The Counter-Use ______________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Daniel W. B. Brown, M.D.

ivision Sign-O Division of Ophthalmic Devices

510(k) Number K011914