SURELASE CO2 LASER SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "CLINICON" in a bold, sans-serif font. To the left of the word is a logo consisting of several geometric shapes, including triangles and parallelograms, arranged to form a stylized design. The overall impression is that of a company logo or brand name, possibly related to the medical or healthcare industry given the name "CLINICON". Clinicon Corporation 3025 Industry Street Suite A Oceanside, CA 92054 760-439-1700 760-439-1798 (FAX) SION FOCUSED" # SECTION 5 - 510(k) Summary 510(k) Summary Preparation Date: - 1. 510(K) Owner: Fritz A. Brauer, President Clinicon Corporation 3025 Industry Street Suite A Oceanside, CA 92054 800-254-6426 / 760-439-1700 / 760-439-1798 (FAX) - 2. 510(k) Contact: Gerald S. Palecki Quality / Regulatory Consultant Palecki Enterprises LLP 1107 259th ST NW Stanwood, WA 98292 760-715-5954 gpalecki@palecki-enterprises.com - 3. Device Trade Name: SureLase Common Name: CO2 Laser System Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810). > "A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide." Classification: Class II Product Code: GEX - 4. Predicate Device(s) The SureLase CO2 Laser System is equivalent in operating principles and intended uses to the Luxar LX-20SP and DEKA SmartXide CO2 Laser Systems. - 5. Device Description and Function The Clinicon SureLase laser system is a mobile platform that utilizes a radio frequency (RF) excited carbon dioxide (CO2) laser tube to produce an infrared beam at a nominal 10.6 µm wavelength at powers adjustable from 2 to 20 Watts Continuous Wave (CVV). Laser energy is conducted to the point of application by a flexible fiber waveguide and handpiece / tip assembly. Laser system operation is controlled by operator input on a touch-screen display panel. The RF laser drive is modulated to provide additional pulsed and superpulse emission modes selected from the laser system control panel. K121580 SEP 25 2012 {1}------------------------------------------------ # SECTION 5 - 510(k) Summary A "calibration port" on the side of the laser system allows checking and setting the power emitted from the distal laser aperture and serves as a check on fiber waveguide transmission efficiency. Laser system power, rates, and durations are adjustable as tabulated below: | Parameter | SureLase | |-------------------------------|-----------| | CW Power (watts) | 2-20 | | Pulsed Power (watts) | 2-20 | | Gated Pulse Width (msec) | 5-500 | | Gated Rep Rate (pps) | 1 or 2-20 | | Superpulse Power (watts) | 2-10 | | Gated Pulse Widths (msec) | 10-500 | | Superpulse Pulse Rates (pps) | 160-375 | | Gated Rep Rate (pps) | 1 or 2-30 | | Peak Power (watts) | > 50 | | Superpulse Pulse Width (usec) | 100 -800 | The laser system has safety features complying with requirements in 21 CFR 1040, Performance Standards for Light Emitting Products; IEC 60601-2-22, Medical electrical equipment –Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment ; and IEC 60825-1, Safety of laser products -Part 1: Equipment classification and requirements. Major safety features are as follows: System On-Off Keyswitch, Emergency Stop Switch, Remote Interlock, Fiber Interlock, Beam Blocking Shutter, Internal Laser Power Detector, RF Power Monitor, and required Laser Safety Labels and Labeling. The laser system, components, and features are illustrated in Figure 1. Laser system physical characteristics are: | Parameter | SureLase | |----------------------|-------------------------| | Dimensions | 40" H x 15" W x 15" D | | Weight (Pounds / Kg) | ~ 47 / ~ 21.3 | | Electrical Power | 115 VAC, 15 A, 50/60 Hz | 3 {2}------------------------------------------------ Delivery System: Flexible Fiber Waveguide; ~ 0.5mm ID.; Handpiece w/collet grip; wavequide tips. - Purge Gas: Provision for external air or inert gas purge through the Fiber and Handpiece / Tip. System Cooling: Air; two thermostatically controlled fans with over-temperature protection. Mobility: 4 wheels and handgrip on console for convenient system positioning. 6. Intended use(s) of the Device The Clinicon SureLase CO2 Laser System is intended for use in laser surgery procedures for incision, excision, vaporization, ablation, coagulation, or cauterization of soft tissue in specialties such as: general surgery, cosmetic surgery, dermatology, gynecology, head & neck surgery, neurosurgery, oral surgery, otorhinolaryngology, pediatric surgery, plastic & reconstructive surgery, podiatry, and urology - 7. Technological Characteristics Comparison to Predicate Devices The technological characteristics comparison to predicate devices is summarized in the following table. | Characteristic | Clinicon Surelase | Luxar LX-20 SP | DEKA SmartXide | |-----------------------|-----------------------------|---------------------------------------------------|-----------------| | Predicate 510(k) | N/A | K953074 | K072159 | | Laser Medium | CO2 | CO2 | CO2 | | Wavelength (µm) | 10.6 | 10.6 | 10.6 | | Laser Drive Source | RF | RF | DC | | Output Power (W) | 2 - 20 | 2 - 20 | 2 - 30 | | Pulsed Power (W) | 2 - 20 | 2 - 20 | 0.5 - 15 | | Gated PW (ms) | 5 - 500 | 5 - 500 | 0.2 - 80 | | Gated Rep. Rate (pps) | 1 or 2 - 20 | 2 - 20 | 5 - 100 | | Super Pulse (W) | 2 - 10 | 2 - 10 | 0.5 - 10 | | Super Pulse Peak (W) | > 50 | 50 | 320 | | Beam Delivery System | Flexible Fiber<br>Waveguide | Articulated Arm or<br>Flexible Fiber<br>Waveguide | Articulated Arm | | System HxWxD (in) | 40 x 15 x 15 | 36 x 14 x 14 | 47 x 19 x 22 | {3}------------------------------------------------ ## SECTION 5 - 510(k) Summary | System Weight (lb) | 47 | 42 | 66 | |--------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | Mobility | 4 Wheels & Handle | 4 Wheels & Handle | 4 Wheels & Handle | | Electrical Power | 115 VAC | 115 VAC | 115 VAC | | Intended Use | Incision, Excision,<br>Vaporization,<br>Ablation,<br>Coagulation, or<br>Cauterization of<br>Soft Tissue | Incision, Excision,<br>Vaporization,<br>Ablation,<br>Coagulation, or<br>Cauterization of<br>Soft Tissue | Incision, Excision,<br>Vaporization,<br>Ablation,<br>Coagulation, or<br>Cauterization of<br>Soft Tissue | #### 8. Performance Testing The SureLase CO2 Laser System has been evaluated for performance equivalent to predicate devices through a combination of (1) verification and validation tests per product requirements and specifications and (2) inspections and tests derived from applicable regulations and safety standards as noted below. - 21 CFR 1040, Performance Standards for Light-emitting Products - IEC 60601-1, Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance - IEC 60601-2-22, Medical electrical equipment Part 2-22: Particular requirements for basic safety and essential performance of surgical. cosmetic, therapeutic and diagnostic laser equipment - IEC 60825-1, Safety of laser products Part 1: Equipment classification, requirements and user's guide ### 9. Animal and Clinical Testing Device performance evaluation did not involve Animal of Clinical Testing. {4}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Clinicon Corporation % Palecki Enterprise, LLP Mr. Gerald S. Palecki Quality/Regulatory Consultant 1107 259TH Street NW Stanwood, Washington 98292 SEP 25 2012 Re: K121580 Trade/Device Name: SureLase 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 8, 2012 Received: August 14, 2012 Dear Mr. Palecki: 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 {5}------------------------------------------------ ### Page 2 - Mr. Gerald S. Palecki 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/CDRH0ffices/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/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/Resourcesfor You/Industry/default.htm. Sincerely yours, Mark McMullen Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## SECTION 4 - Indications for Use 510(k) Number (if known): J/ (21580 Device Name: SureLase CO2 Laser System Indications for Use: The Clinicon SureLase CO2 Laser System is intended for use in laser surgery procedures for incision, excision, vaporization, ablation, coagulation, or cauterization in specialties such as: general surgery, cosmetic surgery, dermatology, gynecology, head & neck surgery, neurosurgery, oral surgery, otorhinolaryngology, pediatric surgery, plastic & reconstructive surgery, podiatry, and urology. #### Prescription Use (Part 21 CFR 801 Subpart D) ## AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Division Sian-Off Office of Surgical, Orthopedic, and Restorative Device 510(k) K121580