YOULASER CO2 LASER SYSTEM

{0}------------------------------------------------ AUG 25 2011 # K111592 #### 510(k) SUMMARY Quanta System YOULASER CO2 Title: Submitter: ! . Quanta System SpA via IV Novembre, 116 Solbiate 21058 Olona VA / Italy Contact: Maurizio Bianchi Regulatory Affairs Manager Date Prepared: July 19th, 2011 Quanta System YOULASER CO2 Device Trade Name: Laser surgical instrument for use in general surgery and Common Name: dermatology Classification Name: Instrument, surgical, powered, laser Predicate Devices: - El.En S.p.A Smart CO2 Laser System (K072159); YOULASER CO2 Laser is indicated for Use incision. Intended excision, ablation, vaporization and coagulation of body Indications for Use: soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic otolaryngology surgery). (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. YOULASER CO2 Laser with the scanning unit is indicated for full ablative skin resurfacing for the following application: Dyschromia, Atrophic + Acne scars, Hypertrophic scars > The scanning modality is intended for the above described use. In this case the handpiece simply enables a laser-tissue interaction in different positions within a specific area. {1}------------------------------------------------ The safety and effectiveness of this scanner/device has not been evaluated as a fractionated scanner/device ### Technological Characteristics: The YOULASER CO2 Laser System includes 1 model : | Models | Wavelength | Laser Power | |-----------------|------------|-------------| | YOULASER<br>CO2 | 10.6μm | 30W | The YOULASER CO2 Laser is composed externally of a metallic shell with a frontal polyurethane panel containing the touch screen display. On this panel the key switch, emergency red push button and the operation led are inserted too. On the rear panel the footswitch connector, the remote interlock, the power switch are located. The laser system is composed of power supply, CO2 laser source with air cooling system, optical bench, arm with CO2 scanner, the articulated control electronics. The electronic, based on a microcontroller, manages the voltage power supply and the CO2 laser source. #### Performance Data Substantial Equivalence: #### None The Quanta System YOULASER CO2 is as safe and effective as the predicate devices. The YOULASER CO2 has the same intended uses and similar indications, technological characteristics, and principles of operation The minor technological as its predicate device. differences between the YOULASER CO2 and its predicate devices raise no new issues of safety or YOULASER effectiveness. Thus, the CO2 is substantially equivalent. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is an abstract symbol resembling a stylized eagle or bird, composed of three curved lines. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Quanta System, S.P.A. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, NW Buffalo, Minnesota 55313 AUG 25 2011 Re: K111592 Trade/Device Name: Youlaser CO2 Laser System 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 11, 2011 Received: August 12, 2011 Dear Mr. Job: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bection b re(i) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate Ior use stated in the encreative to regars) at the Medical Device Amendments, or to commerce phor to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices may nave been results in assee approval of a premarket approval application (PMA). alle Cosment Act (7tel) that do not required to the general controls provisions of the Act. The r ou may, therefore, manel of the Act include requirements for annual registration, listing of gencial controls provisions of vactice, labeling, and prohibitions against misbranding and uevices, good minimaturaling pratised, mot evaluate information related to contract liability additeration. Thease note: ODTCT access as 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 If your device is classified (000 acre) axisting major regulations affecting your device can be fillay be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ Page 2 - Mr. Mark Job Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issualic of a substition with other requirements of the Act that FDA has made a determination that your device complies . You must that FDA has made a determination in a your arries by other Federal agencies. You must or any Federal statures and regulations administed to: registration and listing (21 comply with all the Act's requirements, including, but not seconding of medical comply with all the Act s requirements, included device reporting (reporting of medical CFR Part 807); labeling (21 CFR Parts and CFR Part 807); labeling (21 CFR 801); incural active rupos mores practice requirements as set device-related adverse events) (21 CFR 803); good manufacturing practice require device-related adverse evenis) (2) CFR Pat 820); and if applicable, the electronic forth in the quality systems (QS) regulation (21 CFR Pat 820); and if applicable, 1000-10 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 r (1580) htm for and and and and and and 110ffices/usmal 15809 hm for If you desire specific advice to: your acvice of var siconny of the sales of contributions of Commission go to http://www.rda.gov/Abouti DAVCchiersOnecessor sompliance. Also, please the Center for Devices and Radiological Health's (CDBH) securerlyst notifiestion" (21) CFR Part the Center for Devices and Radiological reality of the entremarket notification" (21 CFR Part note the regulation entitled, "Misbranding by reference under the MDR regulation note the regulation entilled, "Misolanding of reference to promises 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to CFR Part 803), piease go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.html for the CDRH's Office IIII) .//www.raa.governman.governmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the You may obtain other general information on your respectives. Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address (800) 038-2041 of (501) 770 - Frices/Resourcesfor You/Industry/default.htm. Sincerely yours, Mark A. Milkeran Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use Statement 592 510(k) Number (if known): Device Name: YOULASER CO2 #### Indications for Use: YOULASER CO2 Laser is indicated for incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. YOULASER CO2 Laser with the scanning unit is indicated for full ablative skin resurfacing for the following application: Dyschromia, Atrophic + Acne scars, Hypertrophic scars The scanning modality is intended for the above described use. In this case the handpiece simply enables a laser-tissue interaction in different positions within a specific area. The safety and effectiveness of this scanner/device has not been evaluated as a fractionated scanner/device Nil RP Ogden for mxm Division of Surgical, Orthopedic, and Restorative Devices . 510(k) Number K111592 Prescription Use X Use (Part 21 C.F.R. 801 Subpart D) Over-The-Counter (21 C.F.R. 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) AND/OR Concurrence of CDRH, Office of Device Evaluation (ODE)