ADVATX

{0}------------------------------------------------ # APR 1 7 2014 ## 510(k) SUMMARY # AdvaLight ApS ADVATx # 510(k) Owner Name, Address, Telephone Number, Contact Person and Date Prepared AdvaLight ApS Brydehusvej 30 Ballerup DK-2750 Denmark Phone: (+45) 2987 5863 Contact Person: Thomas Lund Date Prepared: March 14, 2014 #### Common or Usual Name Surgical Laser #### Classification Name 21 C.F.R. 878.4810 ### Predicate Devices Norseld Dual Yellow D10B (K032397) Candela Vbeam (K043251) Sciton Joule Multi-Platform System (K101916) Cynosure TriStar Aesthetic Workstation (K033176) #### Intended Use / Indications for Use The ADVATx at 589nm is indicated for use for dermatologic treatment of benign cutaneous vascular lesions including but not limited to: treatment of wrinkles, periocular wrinkles, periorbital wrinkles, facial and leg telangiectasia, rosacea, cherry angiomas, port wine stains, hemangiomas and venous lakes, angioma, spider angioma, Poikiloderma of Civatte, inflammatory acne vulgaris, verrucae/warts, scars, striea, and psoriasis. I {1}------------------------------------------------ The ADVATx at 1319nm is indicated for treatment of fine lines and wrinkles. Treatment of atrophic acne scars. Treatment of mild and moderate inflammatory acne vulgaris. # Technological Characteristics The ADVATx Laser System is a Nd:YAG laser delivering 589nm @-switched pulsed light and 1319nm continuous wave light. This laser system was developed specifically for dermatological treatments. The laser light is delivered to the patient either through a scanner or a hand piece. # Performance Data Electrical safety testing was performed which showed compliance with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-22. Laser safety was evaluated and the ADVATx Laser System was found to comply with IEC 60825-1. System and software validation and verification demonstrate that the ADVATx performs as intended and meets its' specifications. Testing was performed which verified that the laser output spectrum and power are stable both over a single treatment session and long term. # Substantial Equivalence The ADVATx 589nm wavelength is substantially equivalent to the Norseld Dual Yellow D10B Laser System (K032397) and the Candela Vbeam Laser System (K043251). The indications for use statement for the ADVATx for the 589nm wavelength is exactly the same as a subset of the indications for use statement for the Norseld Dual Yellow D10B Laser (K032397) and is very similar to the indications for use statement for the Candela Vbeam 595nm wavelength (K043251). The ADVATx 589 nm wavelength and the predicate devices have the same technological characteristics. The ADVATx and the predicate devices are all stand-alone laser systems in the yellow spectrum that are used primarily for dermatological treatments. Treatment parameters including fluence, spot size, and pulse duration are all within the specifications of the previously cleared predicate devices. All of the devices (ADVATx, Norseld and Candela Vbeam) utilize a fiber connected to a hand piece to deliver the laser energy. Additionally, the ADVATx and the Norseld Dual Yellow D10B can be delivered with an optional scanner. The scanner treatment size for the ADVATx is 5 x 5 mm to 10 x 10 mm which is the same minimum and maximum scan area for the Norseld Dual Yellow D10B. The ADVATx 1319nm wavelength is substantially equivalent to the Sciton Joule Laser System (K101916) and the Cynosure Tristar Laser System 2/3 {2}------------------------------------------------ (K033176). The indications for use statement for the ADVATx for the 1319nm wavelength is exactly the same as the indications for use statement for the Sciton Joule Multi-Platform System (K101916). The ADVATx 1319nm wavelength has the same intended use as the identified predicate devices and may be found to be substantially equivalent to the predicate devices. The ADVATx 1319nm and the predicate devices are all Nd:YAG lasers with a wavelength of 1319nm wavelength (1320nm for the Cynosure predicate). All of the devices (from AdvaLight, Sciton and Cynosure) utilize a fiber connected to a hand piece to deliver the laser energy. Additionally, the ADVATx and the Sciton Joule Multi-Platform System are delivered using an optional scanner. The scanner treatment works on identical principles (single energy spots applied on the skin next to each other at very high speed filling out the complete area). {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles a bird in flight or a flowing ribbon. The logo is in black and white. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 17, 2014 AdvaLight ApS % Ms. Maureen O'Connell O'Connell Regulatory Consultants Incorporated 5 Timber Lane North Reading, Massachusetts 01864 Re: K132976 Trade/Device Name: ADVATx 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: March 14, 2014 Received: March 18, 2014 Dear Ms. O'Connell: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. 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 {4}------------------------------------------------ Page 2 - Ms. Maureen O'Connell 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.goy/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address : http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # David Krause -S Binita S. Ashar, M.D., M.B.A., F.A.C.S. for ' Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page. 510(k) Number (if known) K132976 #### Device Name ADVATx #### Indications for Use (Describe) The ADVATx at 589 nm is indicated for use for dematologic treatment vascular lesions including but not limited to: treatment of wrinkles, periocular wrinkles, facial and leg telangiectasia, rosacea, cherry angiomas, port wine stains, hemangiomas and venous lakes, angiona, Poikiloderma of Civate, inflammatory acne vulgaris, veruces warts, scars, striea, and psoriasis. The ADVATx at 1319 nm is indicated for treatment of fine lines and wrinkles. Treatment of anyment of mild and moderate inflammatory acne vulgaris. Type of Use (Select one or both, as applicable) [ Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. # FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) # Neil R Oa 2014.04.17 13:5 FORM FDA 3881 (1/14) For BSA Page 1 of 2 PSC Publishing Scrvices (301) 443-674) {6}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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