TRIOS SYSTEM

{0}------------------------------------------------ 090399 Image /page/0/Picture/1 description: The image shows the word "VIORA" in a bold, sans-serif font. Above the word is a stylized graphic, resembling an infinity symbol with a curved line extending upwards from the left side. The text and graphic are black against a white background. JUN 1 0 2009 # 510(k) Summary: Trios™ System Company Name: Viora Ltd. Contact Person: Danny Erez CEO Telephone: +972-3-5622248 Fax: +972-3-5622247 E-mail: omri@vioramed.com # Authorized US Agent: Josef Luzon - CEO Viora Inc. 30 Montgomery Street, Suite 660 Jersey City, NJ 07302 Telephone: (201) 332-4100 Fax: (201) 332-4200 E-mail: josef@vioramed.com Date prepared: February 12, 2009 Trade Name: TriosTM System Classification name: Laser surgical instrument for use in general and plastic surgery and in dermatology Common/usual name: Trios IPL System Product Code: - ONF Regulation No.: 878.4810 Class: II Panel identification: General and Plastic Surgery Panel. ર-2 {1}------------------------------------------------ 090399 page 2 of 3 DR / #### Predicate Device: Radiancy Mistral Device from Radiancy (Israel) Ltd, Yavne, Israel, cleared under 510(k) # K072331; IFL Professional System from Cyden Ltd, Swansea, Wales, UK, cleared under 510(k) # K050165; McCue Energist Ultra VPL Intense Pulse Light System from McCue PLC, Southhampton, UK, cleared under 510(k) # K060234 and Lumenis Family of IPL Systems from Lumenis Inc, Santa Clara, CA, USA, cleared under 510(k) # K030527 #### Description of the device: The use of Trios 1 in aesthetic applications is based on the principle of Selective Photothermolysis. According to this principle, pulsed light parameters (wavelength, pulse duration and energy fluence) are chosen to selectively target light sensitive cells while minimizing damage to surrounding tissues. Trios The consists of the following major components: - . Main Console - Operator Control Panel . - . Three Hand Pieces The main console contains the high voltage electronics, the control panel, monitoring modules and the cooling system. The hand pieces house the mechanism which generates the light pulse. The hand piece is connected to the system console by an umbilicus cord containing electrical wiring. Light from a Xenon flash lamp, located in the hand piece, is directed through a long-pass optical filter and focused into a transparent light guide that is placed in contact with the skin. #### Indications for Use: The Trios™ system is indicated for long term stable, or permanent, hair reduction; for the treatment of benign cutaneous vascular lesions and the treatment of benign pigmented lesions and for the treatment of mild to moderate inflammatory Acne Vulgaris. {2}------------------------------------------------ 090399 Page 30f3 VIORA ### Substantial Equivalence: The Trios™ System has the same intended use and the same performance characteristics as the following predicate devices: Radiancy Mistral Device from Radiancy (Israel) Ltd, Yavne, Israel, cleared under 510(k) # K072331; IFL Professional System from Cyden Ltd, Swansea, Wales, UK, cleared under 510(k) # K050165; McCue Energist Ultra VPL Intense Pulse Light System from McCue PLC, Southhampton, UK, cleared under 510(k) # K060234 and Lumenis Family of IPL Systems from Lumenis Inc, Santa Clara, CA, USA, cleared under 510(k) # K030527. The Trios™ System is therefore substantially equivalent to those devices. #### Conclusion - The evaluation of the Trios™ System does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate device. {3}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES 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 graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # JUN 1 0 2009 VIORA Limited % Viora Incorporated Mr. Josef Luzon Chief Executive Officer 30 Montgomery Street, Suite 660 Jersey City, New Jersey 07302 Re: K090399 Trade/Device Name: Trois™ System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology Regulatory Class: II Product Code: ONF Dated: May 31, 2009 Received: June 3, 2009 Dear Mr. Luzon: 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 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 {4}------------------------------------------------ Page 2-Mr. Josef Luzon and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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, Mark N J. Me erson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # INDICATIONS FOR USE 510(k) Number (if known): ko 9 0399 Device Name: Trios™ System Indications for Use: The Trios™ system is indicated for long term stable, or permanent, hair reduction; for the treatment of benign cutaneous vascular lesions and the treatment of benign pigmented lesions and for the treatment of mild to moderate inflammatory Acne Vulgaris. Prescription Use X 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) AeilkR. Ogle (Division Sign Off) (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K090399