ELLEX SLIT LAMP, MODEL 30XL

K063352 · Takagi Seiko Co., Ltd. · HJO · Mar 13, 2007 · Ophthalmic

Device Facts

• Record ID: K063352
• Device Name: ELLEX SLIT LAMP, MODEL 30XL
• Applicant: Takagi Seiko Co., Ltd.
• Product Code: HJO · Ophthalmic
• Decision Date: Mar 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or traumas which affect the structural properties of the anterior eye segment.

Device Story

Ellex 30XL Slit-lamp is an AC-powered biomicroscope used in clinical settings by eye care professionals. Device provides magnified, illuminated view of anterior eye segment (cornea to posterior capsule). Clinician operates device to visualize ocular structures; output is direct optical visualization. Used to aid diagnosis of ocular diseases or trauma. Benefits include enhanced structural assessment of anterior eye segment to inform clinical decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

AC-powered slit-lamp biomicroscope. Consists of optical system for magnification and illumination of anterior eye segment. Class II device (21 CFR 886.1850).

Indications for Use

Indicated for patients requiring examination of the anterior eye segment (cornea epithelium to posterior capsule) to aid in the diagnosis of diseases or traumas affecting structural properties. For use by trained clinicians.

Regulatory Classification

Identification

An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.

Special Controls

*Classification.* Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Takagi Seiko Co, Ltd. c/o Kevin Howard Regulatory Officer Ellex Medical Pty. Ltd. 82 Gilbert Street Adelaide SA, 5000 Australia

MAR 1 3 2007

Re: K063352

Trade/Device Name: Ellex Slit Lamp, Model 30XL Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slit Lamp Biomicroscope Regulatory Class: Class II Product Code: HJO Dated: February 9, 2007 Received: February 12, 2007

Dear Mr. Howard:

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, 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 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

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## Page 2 - Mr. Kevin Howard

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/industry/support/index.html.

Sincerely yours,

M.B. Egclemisi MWD

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

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## Indications for Use

510(k) Number (if known): K063352

Device Name: Ellex 30XL Slit-lamp

Indications for Use:

An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or traumas which affect the structural properties of the anterior eye segment.

Prescription Use V AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mavsha L. Burke Nicholas

on of Ophthalmic Nose and Throat De

510(k) Number_106