EYE SYS VISTA

K973756 · Eyesys Technologies, Inc. · HLQ · Nov 13, 1997 · Ophthalmic

Device Facts

• Record ID: K973756
• Device Name: EYE SYS VISTA
• Applicant: Eyesys Technologies, Inc.
• Product Code: HLQ · Ophthalmic
• Decision Date: Nov 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1350
• Device Class: Class 1

Indications for Use

The Eyesys Uista has the Same intended use as other analysis and topography sustems. It specifically measures, records, and corneal arolyzes corneal curvature in a non-invasive manner. The EyeSys Vista will be operated by dostors and technicians in ophtholmic and optometric offices . Corners topogital pho for potient screening become the standard of care documentation, corneal operative corneal surgery portu defermination and follow- up, as well as assisting in the and follow-up lenses. of contact

Device Story

EyeSys Vista is a non-invasive corneal topography system; measures and records corneal curvature. Operated by doctors and technicians in ophthalmic/optometric offices. Provides corneal topography maps for patient screening, surgical planning, and contact lens fitting. Output used by clinicians to document corneal health and guide clinical decision-making for refractive surgery and contact lens management.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological and intended use comparison to existing topography systems.

Technological Characteristics

Non-invasive corneal topography system; measures corneal curvature. Designed for use in ophthalmic and optometric clinical environments. Technical specifications and materials not detailed in provided documentation.

Indications for Use

Indicated for patients requiring corneal curvature measurement and analysis. Used for patient screening, documentation, pre- and post-operative corneal surgery assessment, and contact lens fitting/follow-up in ophthalmic and optometric settings.

Regulatory Classification

Identification

A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 1997

Ms. Beth A. Soper Premier Laser Systems, Inc. 3 Morgan Irvine, CA 92618

Re: K973756 Trade Name: Eye Sys Vista TM Regulatory Class: I Product Code: 86 HLQ, 86 HJA Dated: September 30, 1997 Received: October 2, 1997

Dear Ms. Soper:

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 (for the indications for use stated in the enclosure) 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 Current Good Manufacturing Practice requirements, 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 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 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 - Ms. Soper

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" (21 CFR 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/dsmamain.html".

Sincerely yours,

A. Roerl Rosenthal

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

Enclosure

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510 (k) Number (if known): K 973 756 Indications For Use

The Eyesys Uista has the Same intended use as other analysis and topography sustems. It specifically measures, records, and corneal arolyzes corneal curvature in a non-invasive manner.

The EyeSys Vista will be operated by dostors and technicians in ophtholmic and optometric offices . Corners topogital pho for potient screening become the standard of care documentation, corneal operative corneal surgery portu defermination and follow- up, as well as assisting in the and follow-up lenses. of contact

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Counter Use

(Optional Formar 1-2-56)

Am Williams
(Division Sign-Off)
Division of Ophthalmic Devices

510(k) Number