NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LR

K955900 · Novavision, Inc. · HQD · Mar 25, 1996 · Ophthalmic

Device Facts

• Record ID: K955900
• Device Name: NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LR
• Applicant: Novavision, Inc.
• Product Code: HQD · Ophthalmic
• Decision Date: Mar 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2
• Attributes: Therapeutic

Device Story

Rigid gas permeable contact lenses (rosilfocon A) for daily wear; available in spherical, multifocal, and bifocal designs; clear or blue tinted; shipped in NovaSoak solution. Intended for vision correction. Used by patients under professional eye care supervision.

Technological Characteristics

Material: rosilfocon A. Type: Rigid Gas Permeable (RGP) contact lens. Designs: spherical, multifocal, bifocal. Tints: clear, blue. Packaging: NovaSoak solution.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAR 25 1996

Dr. Alan J. Touch
NovaVision, Inc.
2700-200 Gateway Centre Blvd.
Morrisville, NC 27560

Re: K955900

Trade Name: NOVALENS/NovaWet spherical and PERCEPTION
and VANGUARD multifocal and/or bifocal (rosilfocon A)
Rigid Gas Permeable Contact Lens (Clear and Blue Tinted)
for Daily Wear (shipped in NovaSoak)

Regulatory Class: II
Product Code: 86 HQD
Dated: December 27, 1995
Received: December 29, 1995

Dear Dr. Touch:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 publish 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 21 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 - Dr. Alan J. Touch

This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. 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), promotion, or advertising please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-300) at [phone]. Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at their toll free number [phone] or at [phone].

Sincerely yours,

Nancy C. Brogdon
Interim Director
Division of Ophthalmic Devices
Office of Device Evaluation
Center for Devices and Radiological Health