FOTONA XP ND: YAG LASER SYSTEM

{0}------------------------------------------------ K113702 Page w of a # 5. 510(k) Summary | Submitter's Name: | Fotona d.d.<br>Stegne 7<br>SI-1000 Ljubljana, Slovenia<br>Phone: +386 15009100<br>Fax: +386 5009 200 | |-------------------|------------------------------------------------------------------------------------------------------| | Contact Person: | Stojan Trošt, QA&RA Manager<br>Phone: +386 1 5009 299<br>E-mail: stojan.trost@fotona.com | MAR 2 8 2012 Date: December 14, 2011 Fotona XP Nd:YAG Laser System Family Device Trade Name: Nd:YAG Surgical Laser Common Name: Instruments, Surgical, Powered, Laser Classification Name: 79-GEX ### DEVICE DESCRIPTION The Fotona XP Nd:YAG Laser System Family is based on thè Nd:YAG (1064 nm) laser technology. There is one optical cavity containing the Nd: YAG crystal. The Nd: YAG laser is activated by means of the use of a flashlamp. After the cavity, a red diode aiming beam is reflected onto a coaxial bcam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by an optical fiber delivery system to an optical handpiece. Optionally, the laser beams can be guided through fiber having SMA905 connector on the proximal end and bare fiber on distal end. The user activates laser emission by means of a footswitch. The Nd: YAG (1064 nm) laser can be operated with variable pulse durations in the range of 0.1-50 msec, with repetition rates up to 100 Hz and laser pulse energies up to 20 J. Depending on the type of treatment, the user can choose between a PULSE mode user interface, and a QCW (Quasi-Continuous Wave) mode user interface. The laser operation is the same for both modes, the difference is only in the laser parameters that can be directly selected from the keyboard. ### INTENDED USE Fotona XP Nd:YAG Laser System Family and its accessories are intended for use in the following procedures: Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: - Matrixectomy ー - Radical nail excision - - Periungual and subungual warts ー - Plantar warts l - Neuromas - - Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes ー Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.) {1}------------------------------------------------ . K113702 Page (2) of (2) ### PREDICATE DEVICES - Cutera GenesisPlus (K103626) l - PinPointe FootLaser (K093547) l ## SUMMARY OF TECHNOLOGICAL CHARACTERISTICS The Fotona XP Laser System Family has identical technological and similar design characteristics as the predicate devices. The output characteristics are for the intended use the same as those of the predicate devices. A comparison of the technical characteristics for the intended use of the Fotona XP Laser System Family with those of the predicate devices is provided in the Table 1 below. | Characteristic | Fotona XP Nd:YAG<br>Laser System Family | PinPointe Footlaser<br>K093547 | Cutera GenesisPlus Laser<br>K103626 | |------------------|-------------------------------------------------------------|---------------------------------------------------------------|-----------------------------------------------------------| | Laser source | Nd:YAG | Nd:YAG | Nd:YAG | | Wavelength | 1064 nm | 1064 nm | 1064 nm | | Laser media | Flashlamp pumped solid<br>state rod | Flashlamp pumped solid<br>state rod | Flashlamp pumped solid<br>state rod | | Aiming beam | 650 nm (≤ 1 mW) | 630-680 nm (≤ 2,5 mW) | 630-680 nm (≤ 2,5 mW) | | Output mode | Pulsed, Multimode | Pulsed, Multimode | Pulsed, Multimode | | Energy per pulse | up to 3,5 J (podiatry)<br>up to 20 J (other<br>indications) | up to 3,5 J | up to 3,5 J | | Pulsewidth | 0,1 - 2 ms (podiatry)<br>0,1 - 50 ms (other<br>indications) | 0,1-3 ms | 0,1-3 ms<br>6-20 ms (other<br>indications) | | Repetition rate | 1 - 100 Hz | 5 - 100 Hz | 5 - 100 Hz | | Output power | up to 30 W | up to 100 W | up to 100 W | | Beam delivery | Fiber | Fiber | Fiber | | Spot sizes | 1 -1.5 mm (podiatry)<br>0,2 - 10 mm (other<br>indications) | 1 -1.5 mm (podiatry)<br>Other spot sizes are not<br>published | 1-1.5 mm (podiatry)<br>up to 13 mm (other<br>indications) | | User interface | Push-button control panel | LCD color touchscreen or<br>push-button control panel | LCD color touchscreen | | Laser activation | Footswitch | Footswitch | Footswitch | | Input power | 230V, 17A 50/60 Hz | 200-240V, 50/60 Hz | NA | | Dimensions | 60x33x82 cm | 33x36x81 cm | NA | | Weight | 78,5 kg (maximum power<br>configuration | 17,2 kg | NA | Table 1: Comparison table between Fotona XP Nd:YAG Laser System Family and predicate device.s ## STATEMENT OF SUBSTANTIAL EQUIVALENCE Fotona XP Nd:Y AG Laser System Family is substantially equivalent to the predicate devices Cutera GenesisPlus (K103626) and PinPointe FootLaser (K093547) in terms of indications for use and technology based on technical and functional characteristics. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with stylized lines representing its wings and body. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 13, 2013 Fotona D.D. % Mr. Stojan Trošt QA/RA Manager Stegne 7 SI-1000 Ljubljana, Slovenia Re: K113702 Trade/Device Name: Fotona XP Nd:YAG Laser System Family 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: PDZ, GEX Dated: February 27, 2012 Received: February 29, 2012 Dear Mr. Trošt: This letter corrects our substantially equivalent letter of March 28, 2012. 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. {3}------------------------------------------------ Page 2 - Mr. Stojan Trošt 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/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.gov/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 Small Manufacturers. International and Consumer Assistance 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, FOR Peter D. Rumm -S Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K!!3702 ## 4. Indications for Use Statement 510(k) Number (if known): #### Device Name: Fotona XP Nd: YAG Laser System Family Fotona XP Nd:YAG Laser System Family is indicated for podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: - Matrixectomy - - Radical nail excision - - Periungual and subungual warts ・ - Plantar warts - - Neuromas - - Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes -Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.) Prescription Use: __ X (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 (ODE) Neil R.P. Dale for mxm Division Sign-Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K113702