HALUX IRIS EXAMINATION AND SURGICAL LAMP

{0}------------------------------------------------ ## EXHIBIT 2 510(k) Summary Waldmann Lighting 9 W. Century Drive Wheeling, IL 60090 Phone: 847-520-1060 Fax: 847-520-1730 Contact: Les Kaminski, Plant Manager Prepared November 5, 2005 - 1. Identification of the Device: Proprietary-Trade Name: Halux® Iris Examination and Surgical Lamp Classification Name: lamp, surgical Codes FTD and FSY .. Common/Usual Name: Surgical lamp - 2. Equivalent legally marketed devices Burton Medical Products Corp Outpatient® Minor Surgical Light, K042395 - 3. Indications for Use (intended use) Halux® Iris is designed to provide the required illumination for surgeries, procedures, and examinations of patients. The Halux® Iris Examination and Surgical Lamp is to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms and all other health care facilities where the need for additional illumination exists. - 4. Description of the Device: Whether in the doctor's office, examination rooms, emergency facilities, intensive care clinics, pre- or post-operative rooms, the Iris provides high intensity light where it is needed. The Iris is user friendly. With its high quality illumination, the halux® Iris is perfect for lighting all kinds of examinations and treatments. Outstanding features of this luminaire include the unique shape of the lamp housing, the combination facetted and parabolic technology of its reflector, and its smooth operating and spring-loaded articulating arm. Highlights of our examination lamp: Smooth Operation and adjustability Precise positioning Compact and enclosed articulation system with counterbalance system. A specially designed reflector system insures a precise light source that renders true colors. The Iris is available in ceiling wall and floor versions. halux® Iris is a medical product manufactured in accordance with EG 93/42 Class 1 and is constructed in accordance with EN 60 601-2-41 (UL2601). - 5. Safety and Effectiveness, comparison to predicate device. The results of bench and laboratory testing indicates that the new device is as safe and effective as the predicate device. {1}------------------------------------------------ ## 6. Substantial Equivalence Chart | Technical Specifications | | | |--------------------------|--------------------------------------|---------------------------------------| | Items | Value | | | Manufacturer | Burton Medical | Waldmann Lighting | | Model number(s) | Outpatient Plus or CoolSpot | Halux® Iris | | K number | K042395 | SAME | | Electrical requirements | 120 V. 50-60 Hz | SAME | | Light Output | 4800 footcandles | 45000 lux at 0.8 m (4180 footcandles) | | Color temperature | 3600 K | 4000 K | | Wattage | 150 watts<br>(three 50 watt halogen) | One 50 watt Halogen | | Power source | Transformer | SAME | | Operating environment | Minor surgeries | SAME | | Bulb operating life | 2000 hrs. | Up to 4000 hrs. | | Case material | Steel and plastics | SAME | | Warranty | 3 years | 2 years | | Safety listing | UL | UL | ## 7. Conclusion After analyzing both bench and user testing data, it is the conclusion of Waldmann Lighting that the Halux® Iris Examination and Surgical Lamp is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 3 2006 Waldmann Lighting c/o Mr. Daniel Kamm, P.E. Kamm & Associates PO Box 7007 Deerfield, Illinois 60015 Re: K053364 Trade/Device Name: Halux® Iris Examination and Surgical Lamp Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FTD Dated: February 13, 2006 Received: February 17, 2006 Dear Mr. Kamm: 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. Kamm 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, peemel -Mark N. Melkerson, M.S. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a black and white abstract shape. The shape is irregular and has a jagged outline. It appears to be a silhouette of an object or figure, but the details are not clear enough to identify it specifically. The image is simple and lacks any background elements. ## Indications for Use KOS3864 510(k) Number (if known): Device Name: Halux® Iris Examination and Surgical Lamp Indication for use: Halux® Iris is designed to provide the required illumination for surgeries, procedures, and examinations of patients. The Halux® Iris Examination and Surgical Lamp is to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms and all other health care facilities where the need for additional illumination exists. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODF) Page 1 of 1 Q.M.De Division Sign-Off Division of General, Restorative, and Neurological Devices K053364 510(k) Numbe