GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72

{0}------------------------------------------------ # K080776 ## Summary of Safety and Effectiveness for the GILRAS Slit Lamp submitted by Al Weisenborn 19526 East Lake Drive Miami, Florida 33015 Phone: (305) 829-3437 SEP - 9 2008 on behalf of USOphthalmic 7255 NW 68th Street Unit # 9 Miami, FL 33166 Phone: (305) 969-4545 Contact Person: Ezequiel D. Lukin Device Trade Name: GILRAS Slit Lamp Common Name: Slit Lamp Classification Name: Biomicroscope, Slit-lamp, AC-powered per 21 CFR § 886.1850 #### Identification of a Legally Marketed Predicate Device The USOphthalmic GILRAS 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 GILRAS Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination. There are 3 models GR-SL36, GR-SL54, and GR-SL72. These models differ only in the supplied accessories. All models have the same operating characteristics and intended use. #### Intended Use The GILRAS Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination of the anterior eve 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. {1}------------------------------------------------ # Summary of Technological Characteristics An 23-point comparison of the technological characteristics of the USOphthalmic GILRAS Slit Lamp and the predicate devices was performed. The devices were found to be substantially equivalent as shown in the table below. | Feature | GILRAS Slit Lamp | 66 Vision-Tech YZ Slit Lamp | |-----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Manufacturer: Shanghai<br>MediWorks Precision Instruments,<br>LTD<br>Relabeler: USOphthalmic | Suzhou 66 Vision-Tech Co., LTD | | Trade name | GILRAS Slit Lamp | 66 Vision-Tech YZ Slit Lamp | | 510(k) Number | K080776 | K033190 | | Intended use | The GILRAS Slit Lamp is an AC-<br>power slit lamp biomicroscope<br>intended for use in eye examination<br>of the anterior eye segment, from the<br>cornea epithelium to the posterior<br>capsule. It is used to aid in the<br>diagnosis of diseases or trauma which<br>affect the structural properties of the<br>anterior eye segments. | The 66 Vision-Tech YZ Slit lamp is<br>an AC-power slit lamp biomicroscope<br>intended for use in eye examination<br>of the anterior eye segment, from the<br>cornea epithelium to the posterior<br>capsule. It is used to aid in the<br>diagnosis of diseases or trauma which<br>affects the structural properties of the<br>anterior eye segment. | | Method of Operation | AC-powered | AC-powered | | Exposure Parameters | 50000 Lux Maximum<br>Continuously adjustable from 0 to<br>50000 Lux | 75000 Lux at position ¼<br>150000 Lux at position ½<br>300000 Lux at position 1 | | Data Collection and/or<br>Display Systems | None | None | | Flammability of<br>Materials | Non-combustion supporting materials | Non-combustion supporting materials | | Maximum temperature<br>of Parts of the Device<br>Held by the Operator or<br>Accessible to the | 30°C | 30°C | | Eyepiece Power | 12.5X | 12.5X | | Total Magnification | GR-SL36 - 10X, 16X, 25X<br>GR-SL54 - 6X, 10X, 16X, 25X, 40X<br>GR-SL72 - 10X, 16X, 25X | 6X, 10X, 16X, 25X, 40X | | Stereo Angle | 13° | 13° | | Diopter Adjustment | -6D to +6D | -5D to +3D | | Pupillary Adjustment: | 55mm to 78.5mm | 55mm to 78.5mm | | Slit Width | Continuous from 14mm to 0mm (at<br>14mm slit becomes a circle) | Continuous from 9mm to 0mm (at<br>14mm slit becomes a circle) | | Feature | GILRAS Slit Lamp | 66 Vision-Tech YZ Slit Lamp | | Slit Length | Continuous from 14mm to 0mm (at<br>14mm,slit becomes a circle) | Continuous from 9mm to 0mm (at<br>14mm, slit becomes a circle) | | Slit Angle | 0 to 180 degree with horizontal<br>scanning capability | 0 to 180 degree with horizontal scan-<br>ning capability | | Aperture Diameters | 14, 8, 5, 3, 0.5,and 0.2mm | 9mm, 8mm, 5mm, 3mm, 2mm, 1mm,<br>0.2mm | | Filters | Heat-absorbing, Neutral Density,<br>Cobalt Blue, and Red-Free | Heat absorption, gray, red-free, and<br>blue | | Slit Inclination | 5°, 10°, 15°, and 20° | 5°, 10°, 15°, and 20° | | Illumination Lamp | 6V, 20W halogen lamp | 12V, 30W halogen lamp | | Hruby Lens | Not available | Optionally Available | | Fixation Target | Green LED | Red LED | | Brightness Controls | Continuously adjustable from 0 to<br>50000 Lux | 3-mode: low, medium and high | | Patient Contact<br>Materials | Chin-rest paper | Chin-rest paper | | | Forehead-rest -<br>Polytetrafluoroethylene | Forehead-rest -<br>Polytetrafluoroethylene | | Beam Splitter | GR-SL36 - No | | | | GR-SL54 - No | Optional | | | GR-SL72 - Yes | | Error! Unknown document property name. Error! Unknown document property name., Error! Unknown document Revised August 21, 2008 property name. {2}------------------------------------------------ ## Summary of Performance Data The USOphthalmic GILRAS Slit Lamp complies with the requirements of listed FDA Recognized Consensus Standards. - ISO 10939:2007, Ophthalmic instruments -- Slit-lamp microscopes . - IEC 60601-1, Medical Electrical Equipment Part 1: General . Requirements for Safety The USOphthalmic GILRAS 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 GILRAS 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. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP - 9 2008 USOphthalmic, LLC c/o Al Weisenborn 7255 NW 68th Street, Unit #9 Miami, FL 33166 Re: K080776 Trade/Device Name: GILRAS Slit Lamp, Models GR-SL36, GR-SL54 and GR-SL72 Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slit-lamp Biomicroscope Regulatory Class: II Product Code: HJO Dated: August 14, 2008 Received: August 15, 2008 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. {4}------------------------------------------------ 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarlee, Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Malvina B. Eggersta, und Malvina B. Eydelman, M.L Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ #### Indications for Use Page 1 of 1 510(k) Number (if known): Device Name: GILRAS Slit Lamp Indications for Use: The GILRAS 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) Danid L. Kaushn (Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises 510(k) Number K080776 Page 1 of 1