GOLDMAN MANUAL TONOMETER

K981432 · Golden Vision, Inc. · HKY · Jan 12, 1999 · Ophthalmic

Device Facts

• Record ID: K981432
• Device Name: GOLDMAN MANUAL TONOMETER
• Applicant: Golden Vision, Inc.
• Product Code: HKY · Ophthalmic
• Decision Date: Jan 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1930
• Device Class: Class 2

Intended Use

THE GOLDMAN MANUAL TONOMETER IS AN APPLIANCE THAT SERVES TO MEASURE INTRACCULARY RESURE, NOORDING TO THE GOLDMAN METHOD. THE TO MEINTAIN A UNIFORM APPLANATION OF THE SURFACE OF THE CORNEA. IT IS SPECIALLY INDICATED IN GLAUCOMA DISEASE.

Device Story

Manual tonometer; measures intraocular pressure via Goldmann applanation method; maintains uniform corneal surface applanation; used by clinicians in ophthalmic settings; provides physical pressure measurement to assist in glaucoma diagnosis and management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual mechanical tonometer; Goldmann applanation principle; Class II device; Product Code HKY.

Indications for Use

Indicated for patients with glaucoma disease requiring intraocular pressure measurement via the Goldmann applanation method.

Regulatory Classification

Identification

A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Golden Vision, Inc. Mr. Andres R. Quiroz, President 7436 S.W. 117th Ave, Suite 103 Miami, FL 33183

Re: K981432

Trade/Device Name: Haag-Streit Goldmann Manual Tonometer Regulation Number: 886.1930 Regulation Name: Tonometer and accessories Regulatory Class: II Product Code: HK Y Dated: October 9, 1998 Received: October 15, 1998

Dear Mr. Quiroz:

This letter corrects our substantially equivalent letter of January 12, 1999.

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 (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 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.

{1}------------------------------------------------

This letter will allow you to continue 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/dsma/dsmamain.html

Sincerely yours,

Everett T. Beers PhD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

ATTACHMENT 4

## GOLDEN VISION, INC.

7436 S.W. 117th AVE., SUITE 103 MIAMI, FLORIDA 33183 PHONE [phone] FAX [phone]

ATTACH. 4

510(k) 981432

DEVICE NAME:

## GOLDMAN MANUAL TONOMETER

INDICTIONS FOR USE: THE GOLDMAN MANUAL TONOMETER IS AN APPLIANCE THAT SERVES INDICTIONS FOR USE. THE GOEDRANTS ACCORDING TO THE GOLDMAN METHOD. THE TO MEASURE INTRACCULARY RESURE, NOORDING TO MEINTAIN A UNIFORM APPLANATION OF THE SURFACE OF THE CORNEA.

IT IS SPECIALLY INDICATED IN GLAUCOMA DISEASE.

.L.B. hicholas

Division Sign-Off) Division of Ophthalmic Devices K981432 10(k) Number _

Prescription Use
(Per 21 CFR 801.109)

/s/ B Nicholas

(Per 21 CFR 801.109)