LUXVISION SLIT LAMP

K063416 · Us Ophthalmic, LLC · HJO · Dec 7, 2006 · Ophthalmic

Device Facts

• Record ID: K063416
• Device Name: LUXVISION SLIT LAMP
• Applicant: Us Ophthalmic, LLC
• Product Code: HJO · Ophthalmic
• Decision Date: Dec 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

The Luxvision Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye 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 trauma which affect the structural properties of the anterior eye segments.

Device Story

Luxvision Slit Lamp (models LS880, LS1100, LS1400) is an AC-powered biomicroscope used by clinicians for examination of the anterior eye segment. Device provides magnified visualization of ocular structures to assist in diagnosing diseases or trauma. Operation involves standard slit lamp illumination and observation techniques. No automated processing or software-based analysis is involved.

Clinical Evidence

Bench testing only. Compliance with ISO 10939:1998 (Ophthalmic instruments - Slit-lamp microscopes) and IEC 60601-1 (Medical Electrical Equipment - General Requirements for Safety) demonstrated.

Technological Characteristics

AC-powered slit lamp biomicroscope. Models differ by supplied accessories. Complies with ISO 10939:1998 and IEC 60601-1. No software or digital processing components.

Indications for Use

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

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.

Predicate Devices

• 66 Vision-Tech YZ Slit Lamp (K033190)

Submission Summary (Full Text)

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

063410

## Summary of Safety and Effectiveness for the Luxvision Slit Lamp

DEC - 7 2006

submitted by USOphthalmic 7255 NW 68th Street Unit # 9 Miami, FL 33186 Phone: [phone]

Ezequiel D. Lukin Contact Person: Device Trade Name: Luxvision Slit Lamp Common Name: Slit Lamp Biomicroscope, Slit-lamp, AC-powered per 21 CFR § 886.1850 Classification Name:

### Identification of a Legally Marketed Predicate Device

The USOphthalmic Luxvision Slit Lamp is substantially equivalent to 66 Vision-Tech YZ Slit Lamp that is legally marketed and distributed by Suzhou 66 Vision-Tech Co., LTD pursuant to premarket notification K033190.

### Device Description

The Luxvision Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination There are 3 models LS880, LS1100, and LS1400. These models differ only in the supplied accessories. All models have the same operating characteristics and intended use.

### Intended Use

The Luxvision Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye 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 trauma which affect the structural properties of the anterior eye segments.

### Summary of Technological Characteristics

An 8-point comparison of technological characteristics of the USOphthalmic Luxvision Slit Lamp and the predicate devices was performed. The devices were found to be substantially equivalent.

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

# Summary of Performance Data

The USOphthalmic Luxvision Slit Lamp complies with the requirements of listed FDA Recognized Consensus Standards.

- ISO 10939:1998, Ophthalmic instruments -- Slit-lamp microscopes .
- . IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety

The USOphthalmic Luxvision Slit Lamp is substantially equivalent to the 66 Vision-Tech YZ Slit Lamp that is legally marketed and distributed by Suzhou 66 Vision-Tech Co., LTD. This has been demonstrated through a 8-point technological comparison of features.

Because the USOphthalmic Luxvision Slit Lamp meets the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 7 2006

U. S. Ophthalmic LLC c/o Mr. Al Weisenborn 7255 NW 68th St. Unit #9 Miami, FL 33166

Re: K063416

Trade/Device Name: Luxvision Slit Lamp (Models LSL880, LSL 1100, and LSL 1400) Regulation Number: 21 CFR 886.1850 Regulation Name: Slit Lamp Regulatory Class: II Product Code: HJO Dated: November 3, 2006 Received: November 13, 2006

Dear Mr. Weisenborn:

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 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.

{3}------------------------------------------------

#### Page 2 – Mr. Al Weisenborn

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. Eychlesheimer MD

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

{4}------------------------------------------------

#### Indications for Use

Page 1 of 1

0634 510(k) Number (if known):

Device Name: Luxvision Slit Lamp

Indications for Use:

The Luxvision Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye 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 trauma which affect the structural properties of the anterior eye segments.

Prescription Use X (Per 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)

Daryl L. Kaufman

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

**510(k) Number** K063416

Page 1 of 1

USOphthalmic

November 3, 2006