← Product Code [MMQ](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MMQ) · K964702

# EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800 (K964702)

_Euclid Systems Corp. · MMQ · May 20, 1997 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MMQ/K964702

## Device Facts

- **Applicant:** Euclid Systems Corp.
- **Product Code:** [MMQ](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MMQ.md)
- **Decision Date:** May 20, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1350
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Indications for Use

Indicated for use for measuring the shape and curvature of the anterior surface of the cornea of the eye and for displaying the topographical maps of the surface of the cornea. This information can be used to analyze, monitor and evaluate the shape and symmetry of the cornea following refractive surgery, to assist in the diagnosis of keratoconus, to assist in the fitting of contact lenses, to assist in the understanding of various corneal irregularities such as those induced by post operative sutures and wounds, and to assist in the understanding of various refractive conditions of the cornea, such as myopia, hyperopia, and astigmatism.

## Device Story

The Euclid Corneal Topography System (ET800) measures and maps the anterior corneal surface. It captures corneal curvature data to generate topographical maps. Used in clinical settings by eye care professionals to analyze corneal symmetry, monitor post-refractive surgery outcomes, diagnose keratoconus, assist in contact lens fitting, and evaluate corneal irregularities or refractive conditions. The system provides visual maps and analytical data to support clinical decision-making regarding corneal health and vision correction.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Corneal topographer designed for anterior surface measurement and mapping. System utilizes optical sensing to determine corneal curvature and shape. Output consists of topographical maps and analytical data for clinical evaluation.

## Regulatory 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 20 1997

Euclid Systems Corporation
c/o Ms. Paula Tirrell
Regulatory Assistant
Schiff & Company®
1129 Bloomfield Avenue
West Caldwell, NJ 07006

Re: K964702
Trade Name: Euclid Systems Corneal
Topographer Model ET800
Regulatory Class: I
Product Code: 86 MMQ
Dated: March 25, 1997
Received: March 28, 1997

Dear Ms. Tirrell:

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 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 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. Paula Tirrell

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 (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" (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 (800) 638-2041 or at (301) 443-6597.

Sincerely yours,

![img-0.jpeg](img-0.jpeg)

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) Premarket Notification
Euclid Systems Corporation - ET800 Corneal Topography System

510(k) Number (if known): K 964702

Device Name: EUCLID CORNEAL TOPOGRAPHY SYSTEM

Indications for Use:

Corneal Topographer:

Indicated for use for measuring the shape and curvature of the anterior surface of the cornea of the eye and for displaying the topographical maps of the surface of the cornea. This information can be used to analyze, monitor and evaluate the shape and symmetry of the cornea following refractive surgery, to assist in the diagnosis of keratoconus, to assist in the fitting of contact lenses, to assist in the understanding of various corneal irregularities such as those induced by post operative sutures and wounds, and to assist in the understanding of various refractive conditions of the cornea, such as myopia, hyperopia, and astigmatism.

(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 Use ☐
(Per 21 CFR 801.109)
(Optional Format 1-2-96)

Drew M. M. (Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K 964702

Prepared by Schiff & Company, West Caldwell, NJ
Page 10
CK = 34

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