LUNEAU STERILE TONOMETER SEPARATION PRISMS

K023838 · Luneau SA · HKY · Feb 20, 2003 · Ophthalmic

Device Facts

• Record ID: K023838
• Device Name: LUNEAU STERILE TONOMETER SEPARATION PRISMS
• Applicant: Luneau SA
• Product Code: HKY · Ophthalmic
• Decision Date: Feb 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1930
• Device Class: Class 2

Intended Use

The tonometer separation prisms is an accessory to the tonometer which is a manual device used to measure the intraocular pressure of the eye.

Device Story

Luneau tonometer separation prisms are optical plastic accessories used with manual tonometers. The device consists of a transparent monobloc piece featuring one planar surface for contact with the eye and two small prisms. During ophthalmic examination, the prisms allow the clinician to observe two half-circles, facilitating the measurement of intraocular pressure. The device is used in clinical settings by ophthalmologists to assist in the assessment of ocular health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Optical plastic monobloc construction; transparent; single planar contact surface; dual-prism geometry for visual field splitting. Manual device; no energy source or software.

Indications for Use

Indicated for use as an accessory to a manual tonometer for measuring intraocular pressure in patients requiring ophthalmic examination.

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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 2 0 2003

LUNEAU S.A c/o Jean Noel Young B.P. 252 28005 Chartres Cedex France

Re: K023838

> Trade/Device Name: Luneau tonometer separation prisms Regulation Number: 886.1930 Regulation Name: Manual tonometer Regulatory Class: II Product Code: HKY Dated: February 6, 2003 Received: February 10, 2003

Dear Mr. Young:

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 application (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. Iisting 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 such 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.

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Page 2 - Mr. Jean Noel Young

This letter will allow you to begin 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 vours.

A halpi korenthal

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

Enclosure

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510 (k) NUMBER (IF KNOWN) : Not yet allocated.

Luneau tonometer separation prisms. DEVICE NAME:

INDICATIONS FOR USE:

Indications for use :

The tonometer separation prisms is an accessory to the tonometer which is a manual device used to measure the intraocular pressure of the eye.

Description of the device : .

The Luneau tonometer separation prisms is an optical plastic monobloc piece which is transparent made of 1 plane surface in contact with the eye and of 2 small prisms allowing the ophthalmologists to observe 2 half circles.

(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

Over-The-Counter-Use (Optional Format 1-

Dennis L. McCarthy
(Division Sign Off)

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number K023838