PSL PORTABLE SLIT LAMP

K061330 · Reichert, Inc. · HJO · May 25, 2006 · Ophthalmic

Device Facts

• Record ID: K061330
• Device Name: PSL PORTABLE SLIT LAMP
• Applicant: Reichert, Inc.
• Product Code: HJO · Ophthalmic
• Decision Date: May 25, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 886.1850
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

A slitlamp biomicroscope is intended for use in eye examination of - the anterior segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

Device Story

PSL Portable Slit Lamp is a handheld biomicroscope used by eye care professionals for clinical examination of the anterior eye segment. Device provides magnified visualization of ocular structures to assist in diagnosing diseases or trauma. Operates as a traditional optical slit lamp; requires no complex data processing or software. Used in clinical settings for patient assessment; output is direct visual observation by the clinician. Benefits include portability for examinations outside of standard stationary slit lamp setups.

Clinical Evidence

No clinical data provided; device is a standard optical instrument for which safety and effectiveness are established through design and performance characteristics.

Technological Characteristics

Portable optical biomicroscope; utilizes standard slit lamp illumination and magnification optics. No electronic, software, or algorithmic components. Standalone device.

Indications for Use

Indicated for eye examination of the anterior segment (cornea epithelium to posterior capsule) to aid in the diagnosis of diseases or trauma affecting the structural properties of the anterior eye segment. For prescription use.

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

Reichert, Inc. c/o Mr. Neil E. Devine Intertek Testing Services 2307 East Aurora Road Twinsburg, OH 44087

MAY 2 5 2006

Re: K061330

Trade/Device Name: PSL Portable Slit Lamp Regulation Number: 21 CFR 886.1850 Regulation Name: Slit Lamp Regulatory Class: II Product Code: HJO Dated: May 11, 2006 Received: May 12, 2006

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your been wind the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered processified 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 r ou may, ateres, include 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 he 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. Neil E. Devine

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/cdrl/industry/support/index.html.

Sincerely yours,

M.B. Eychhaus - M.D.

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):____

Device Name: PSL Portable Slit Lamp

Indications for Use:

A slitlamp biomicroscope is intended for use in eye examination of - the anterior segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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)

Denis L. McCarthy

510(k) Number K061330

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