FOXQ 980 LASER

{0}------------------------------------------------ K09/03-9 ## 510(k) SUMMARY - Fox Q-980 Laser Applicant Name: A.R.C. Laser GmbH Fox Q-980 (K073322), LaserPro980 (K082721), vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, Fox Q-980 is a standard diode medical laser with 980nm Indicated for surgical applications requiring the ablation, ophthalmology, pulmonology, thoracic surgery and laser Bessemerstr. 14, D-90411 Nurnberg, Germany Angela Thyzel, General Manager Contact Person: July 30, 2009 Date Prepared: Fox Q-980 Laser Device Trade Name: AUG 1 3 2009 Device Common Name: Classification Name: Diode Laser Laser Surgical Instrument wavelength and quartz fibers assisted lipolvsis. Predicate Devices: Device Description: Intended Use: Device Technological Characteristics and Comparison to Predicate Device(s): Performance Standards: The Fox Q-980 uses diodes to generate energy in the 980 nm range. It is the same 980 laser cleared under K073322 with the added indication for liploysis. Another commercially available diode laser also indicated for laser assisted lipolysis is the LaserPro 980, cleared under K082721. Fibers deliver energy to the tissue for both laser models. The Fox Q-980 Laser complies with the performance requirements of 21CFR 1040.10 and 1040.11. with permissible deviations defined in Laser Notice 50, dated July 26, 2001. The diode lasers also comply with IEC 60601-1:1998 including amendment 1, IEC 60601-2-22:1995, and IEC 60825-1:1993 including amendments 1 and 2. Sterilization of the fibers is in compliance with ISO 11135-1 and 2. Conclusion: The Fox Q- 980 Laser is substantially equivalent to the predicate devices. It is the same 980 nm laser cleared under K073322 and is also indicated for laser assisted lipolysis as is the LaserPro device. {1}------------------------------------------------ Image /page/1/Picture/0 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 extending from its back, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002 A.R.C. Laser GmbH % PPD Medical Device Ms. Kirsten H. Paulson Manager, Regulatory Affairs 3202 Tower Oaks Boulevard, Suite 300 Rockville, Maryland 20852 AUG 1 8 2009 Re: K091059 Trade/Device Name: Fox Q-980 nm Diode Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: August 4, 2009 Received: August 5, 2009 Dear Ms. Paulson: 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 and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical {2}------------------------------------------------ Page 2 - Ms. Kirsten H. Paulson 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, Sincerely yours, Mark N. Millerson Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Indications for Use 510(k) Number (if known): ِ Device Name: Fox Q-980 nm Diode Laser Indications for Use: The Fox Q-980 Diode Laser is indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, thoracic surgery and laser assisted lipolysis. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE RELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (Divisione Siggenoel of CDRH, Office of Device Evaluation (ODE) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K091059