LIGHTSCALPEL

{0}------------------------------------------------ K123037 1/4 Image /page/0/Picture/1 description: The image contains the words "light" and "Scalpel". The word "light" is in bold font and is connected to the letter "S" in "Scalpel" by a curved line. There is a star-like symbol below the word "light" and a horizontal line at the bottom of the image. LightScalpel LLC 16932 Woodinville-Redmond Rd NE, Suite 206 Woodinville. WA 98072 PH: 425-368-1588 FAX: 425-483-6015 # SECTION 5 - 510(k) Summary NOV 2 9 2012 510(k) Summary Preparation Date: - 1. 510(K) Owner: Light Scalpel LLC 16932 Woodinville-Redmond Road NE, Suite 206 Woodinville, WA 98072 866-697-7548 / 425-368-1588 / 425-483-6015 (FAX) - 2. 510(k) Contact: David Walters General Manager 16932 Woodinville-Redmond Road NE, Suite 206 Woodinville, WA 98072 866-697-7548 / 425-368-1588 / 425-483-6015 (FAX) dwalters@lightscalpel.com - 3. Device Trade Name: LightScalpel LS-10 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 LightScalpel 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 LightScalpel LS-10 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 10 Watts Continuous Wave (CW). Laser energy is conducted to the point of application by a flexible fiber wavequide and handpiece 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. {1}------------------------------------------------ 12 3037 2/4 Image /page/1/Picture/1 description: The image shows the logo for "light Scalpel". The word "light" is in bold, and the "S" in "Scalpel" is stylized as a curved line that extends from the bottom left of the image, where it is depicted as a starburst. The rest of the word "Scalpel" is in a regular font. LightScalpel LLC 16932 Woodinville-Redmond Rd NE, Suite 206 Woodinville, WA 98072 PH: 425-368-1588 FAX: 425-483-6015 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 | LightScalpel LS-10 | |-------------------------------|--------------------| | CW Power (watts) | 2 - 10 | | Pulsed Power (watts) | 2 - 10 | | Gated Pulse Width (msec) | 5 - 500 | | Gated Rep Rate (pps) | 1 or 2 - 20 | | Single Pulse Energy (mJ) | 10 - 5000 | | Superpulse Power (watts-avg.) | 2 - 5 | | Gated Pulse Widths (msec) | 10 - 500 | | Superpulse Pulse Rates (pps) | 160 - 375 | | Gated Rep Rate (pps) | 1 or 2 - 30 | | Superpulse Peak Power (watts) | 30 | | 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: {2}------------------------------------------------ <123037 3/4 Image /page/2/Picture/1 description: The image shows the words "light Scalpel" in a stylized font. The word "light" is in bold, and the "S" in "Scalpel" is connected to the "t" in "light" with a curved line. There is a star-like symbol below the word "light." LightScalpel LLC 16932 Woodinville-Redmond Rd NE, Suite 206 Woodinville, WA 98072 PH: 425-368-1588 FAX: 425-483-6015 | Parameter | LightScalpel LS-10 | |----------------------|--------------------------| | Dimensions | 34" H x 15" W x 15" D | | Weight (Pounds / Kg) | ~ 35 / ~ 16 | | Electrical Power | 115 VAC, 7.5 A, 50/60 Hz | Delivery System: Flexible Fiber Waveguide; ~ 0.7mm ID.; Handpiece w/internal focusing lens. Purge Gas: Internal air pump purge through the Fiber and Handpiece. 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 LightScalpel CO2 Laser System is intended for use in laser surgery procedures for incision, excision, vaporization, ablation, or coagulation of soft tissue in specialties such as: general surgery, dermatology, gynecology, oral surgery, otorhinolaryngology, 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 | LightScalpel | 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 - 10 | 2 - 20 | 2 - 30 | | Pulsed Power (W) | 2 - 10 | 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 - 5 | 2 - 10 | 0.5 - 10 | K123037_Sec5_Sum2 {3}------------------------------------------------ K1230374/4 Image /page/3/Picture/15 description: The image contains the words "light" and "scalpel". The word "light" is in bold font and the word "scalpel" is in a thinner font. There is a line that starts with a star-like shape and curves over the word "light" and connects to the letter "S" in the word "scalpel". ### LightScalpel LLC 16932 Woodinville-Redmond Rd NE, Suite 206 Woodinville, WA 98072 PH: 425-368-1588 FAX: 425-483-6015 | Superpulse Peak (W) | 30 | 50 | 320 | |----------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | Beam Delivery System | Flexible Fiber<br>Waveguide | Articulated Arm or<br>Flexible Fiber<br>Waveguide | Articulated Arm | | System HxWxD (in) | 34 x 15 x 15 | 36 x 14 x 14 | 47 x 19 x 22 | | System Weight (lb) | 35 | 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, or<br>Coagulation of Soft<br>Tissue | Incision, Excision,<br>Vaporization,<br>Ablation or,<br>Coagulation of Soft<br>Tissue | Incision, Excision,<br>Vaporization,<br>Ablation, or<br>Coagulation of Soft<br>Tissue | | | | | | ## 8. Performance Testing The LightScalpel LS-10 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. - 10. A comparison between the LS-10 and the predicated carbon dioxide lasers showed that these devices have similar laser characteristics and output parameters and therefore a determination of equivalence can be made between the predicate devices and the LS-10. {4}------------------------------------------------ Image /page/4/Picture/0 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 bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. ### DEPARTMENT OF HEALTH & HUMAN SERVICES #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 LightScalpel, LLC % Mr. David Walters General Manager 16932 Woodinville Redmond Road Northeast Suite 206 Woodinville, Washington 98072 November 29, 2012 Re: K123037 Trade/Device Name: LightScalpel LS-10 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: October 30, 2012 Received: October 31, 2012 Dear Mr. Walters: 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. David Walters CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 vou 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. # Peter D. Rumm -S Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the words "light" and "calpel" in a stylized font. The word "light" is in bold, while "calpel" is in a more cursive font. A line extends from the "S" in "calpel" to a star-like symbol below the words. ## SECTION 4 - Indications for Use 510(k) Number (if known): K123037 Device Name: LightScalpel LS-10 CQ2 Laser System Indications for Use: The LightScalpel LS-10 CO2 Laser System is intended for use in laser surgery procedures for incision, excision, vaporization, ablation, or coagulation of soft tissue in specialties such as: general surgery, dermatology, gynecology, oral surgery, otorhinolaryngology, 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) # Neil R Ogden 2012.11.29 10:42:22 -05'00' (Division Sign-off) Division of Surgical Devices 510(k) Number LS_Sec4_Ind_510(k) Section 4 Page 1 of 1