LIGHTSCALPEL

{0}------------------------------------------------ Image /page/0/Picture/0 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 at the bottom of the curved line, and a degree symbol above the "l" in "Scalpel". # VOL 006 - 510(k) Summary 3 510(k) Summary Preparation Date: 27 November 2013. - 1. 510(K) Owner: LightScalpel® LLC 16932 Woodinville-Redmond Road NE, Suite 107 Woodinville, WA 98072 866-697-7548 / 425-368-1588 / 425-368-1568 (FAX) - 2. 510(k) Contact: David Walters General Manager 16932 Woodinville-Redmond Road NE, Suite 107 Woodinville, WA 98072 866-697-7548 / 425-368-1588 / 425-368-1568 (FAX) dwalters@lightscalpel.com 3. Device Trade Name: LightScalpel® LS-1005 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 LS-10 / LS-1005 CO2 Laser System was previously cleared per K123037. Additional Indications for Use are equivalent to the following predicates: - K081612, Aesculight / K121471, LightScalpel Laser Accessories 4.1 - 4.2 K960475, Luxar LX20 CO2 Laser System - K091320, Lutronic Spectra DENTA II CO2 Laser System 4.3 - 4.4 K100416, Lumenis AcuPulse CO2 Laser System - 4.5 K971743, Sharplan 15F CO2 Laser System JAN - 2 2014 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for "light Scalpel". The word "light" is in bold, lowercase letters, and the word "Scalpel" is in regular font, with the "S" stylized as a curved line extending from the top of the "t" in "light". There is a starburst design below the word "light" and a degree symbol after the word "Scalpel". #### Device Description and Function 5. The LightScalpel LS-1005 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. 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 wavequide transmission efficiency. Laser system power, rates, and durations are adjustable as tabulated below: | Parameter | LightScalpel LS-1005 | |-------------------------------|----------------------| | 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: Equipmentclassification and requirements. Major safety features are as follows: {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for "light Scalpel". The word "light" is in bold, lowercase letters. The word "Scalpel" is in lowercase letters, but the "S" is stylized with a curved line that extends from the top of the "S" and underlines the word "light". There is a small star-like symbol below the word "light". 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 | LightScalpel LS-10 | |----------------------|--------------------------| | Dimensions | 40" H x 15" W x 15" D | | Weight (Pounds / Kg) | ~ 47 /~ 21 | | Electrical Power | 115 VAC, 7.5 A, 50/60 Hz | Delivery System: Flexible Fiber Wavequide; ~ 0.7mm ID .; Handpieces with internal focusing lens ("tipless") and with disposable pre-sterilized ceramic tips. Purge Gas: Internal air pump purge through the Fiber and Handpiece. System Cooling: Air; two thermostatically controlled fans with over-temperature profection. 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, dentistry and oral surgery, otorhinolaryngology, plastic & reconstructive surgery, podiatry, and urology. # Dental Procedures: Gingivectory - Removal of hyperplasias: Gingivoplasty: Papillectomy: Vestibuloplasty: Epulis; Sulcular Debridement; Removal of soft tissue, cysts, and fibroma (non-malignant tumor, mucosa, tongue); Extraction site hemostasis; treatment of ulcerous lesions, including aphthous ulcers; A heat source to activate tooth bleaching materials: Laser Assisted New Attachment Procedure (cementum-mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium). # Oral Surgery Procedures: Frenum Release/Frenectomy: Drainage (abscess): Flap Surgery; Biopsy (incisional & excisional); Aphthous Ulcers (incision & excision); Incision of Infection when used with Antibiotic Surgery; Excision & Ablation of lesions, benign & malignant oral cavity tumors, and hemangiomas: Salivary Gland Pathologies; Preprosthetic Gum Preparation, Leukoplakia; Partial Glossectomy; Peridontial Gum Resection; Homeostasis; Operculectomy: Crown Lengthening (soft tissue). 001 Sum2 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for "light Scalpel". The word "light" is in bold, and the word "scalpel" is in a regular font. A curved line extends from the "l" in "scalpel" and ends in a starburst. # 7. Technological Characteristics Comparison to Predicate Devices The technological characteristics comparison to predicate devices is summarized in the following table. | Predicate 510(k) | LS-1005<br>K123037<br>K132661 | AE-LS Acc.<br>K081612 /<br>K121471 | Luxar<br>LX-20 SP<br>K960475 | Lutronic<br>DENTA II<br>K091320 | Lumenis<br>AcuPulse™<br>K100415 | |-----------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------| | Characteristic | -- | -- | -- | -- | -- | | Laser Medium | CO2 | CO2 | CO2 | CO2 | CO2 | | Wavelength (µm) | 10.6 | 10.6 | 10.6 | 10.6 | 10.6 | | Laser Drive Source | RF | N/A | RF | DC | DC | | Output Power (W) | 2-10 | N/A | 2-20 | 0.5 - 25 | 1 - 30 | | Pulsed Power (W) | 2-10 | N/A | 2-20 | .1 - 7 | 1 - 25 | | Gated PW (ms) | 5-500 | N/A | 5-500 | .004 - 5 | 50 - 1000 | | Gated Rep. Rate (pps) | 1 or 2-20 | N/A | 2-20 | 1 - 180 /<br>1 - 700 | 1 - 100 | | Superpulse (W) | 2-5 | N/A | 2-10 | .1 - 7 | .5 - 10 | | Superpulse Peak (W) | 30 | N/A | 50 | N/A | N/A | | Beam Delivery System | Flexible Fiber<br>Waveguide | Flexible Fiber<br>Waveguide | Flexible Fiber<br>Waveguide | Articulated<br>Arm | Articulated<br>Arm | | System HxWxD (in) | 40x15x15 | N/A | 36x14x14 | 39x14x18 | 47x15x16 | | System Weight (lb) | 47 | N/A | 42 | 77 | 108 | | Mobility | 4 Wheels &<br>Handle | N/A | 4 Wheels &<br>Handle | 4 Wheels &<br>Handle | 4 Wheels &<br>Handle | | Intended Use | Incision,<br>Excision,<br>Vaporization,<br>Ablation, and/or<br>Coagulation of<br>Soft Tissue | Incision,<br>Excision,<br>Vaporization,<br>Ablation,<br>and/or<br>Coagulation of<br>Soft Tissue | Incision,<br>Excision,<br>Vaporization,<br>Ablation,<br>and/or<br>Coagulation of<br>Soft Tissue | Incision,<br>Excision,<br>Vaporization,<br>Ablation,<br>and/or<br>Coagulation of<br>Soft Tissue | Incision,<br>Excision,<br>Vaporization,<br>Ablation, and/or<br>Coagulation of<br>Soft Tissue | | Line Voltage - Nom. | 115 VAC | N/A | 115 VAC | 110/220 VAC | 100-240 VAC | . K132661 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for "light Scalpel". The word "light" is in bold, lowercase letters. The word "Scalpel" is in lowercase letters, but not bold. A curved line starts at the top of the "l" in "light", goes over the words, and ends with a starburst below the words. LightScalpel® LLC 16932 Woodinville-Redmond Rd NE, Suite 107 Woodinville, WA 98072 PH: 425-368-1588 FAX: 425-368-1568- K132661 - 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. Conclusions A comparison between the LS-1005 and the predicated carbon dioxide lasers shows 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-1005. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is smaller than the central symbol. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 2, 2014 LightScalpel LLC Mr. David Walters General Manager 16932 Woodinville-Redmond Road Northeast, Suite 107 Woodinville, Washington 98072 Re: K132661 Trade/Device Name: LightScalpel LS-1005 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: December 3, 2013 Received: December 5, 2013 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical {6}------------------------------------------------ Page 2 - Mr. David Walters ... ... ... ... ... .. 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.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 vours. Binita S. Ashat 2014.01.02 00.500. Binita S. Ashar, MD, MBA, FACS Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # Indications for Use ### 510(k) Number (if known): K132661 Device Name: LightScalpel® LS-1005 CO2 Laser System ### Indications for Use: The LightScalpel LS-1005 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, dentistry and oral surgery, otorhinolaryngology, plastic and reconstructive surgery, podiatry, and urology. #### Dental Procedures: Gingivectomy - Removal of hyperplasias; Gingivoplasty; Papillectomy; Vestibuloplasty; Epulis: Sulcular Debridement; Removal of soft tissue, cysts, and fibroma (non-malignant turnor, mucosa, tongue); Extraction site hemostasis; treatment of ulcerous lesions, including aphthous ulcers; A heat source to activate tooth bleaching materials; Laser Assisted New Attachment Procedure (cementum-mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium). ### Oral Surgery Procedures: Frenum Release/Frenectomy; Drainage (abscess); Flap Surgery; Biopsy (incisional & excisional); Aphthous Ulcers (incision & excision); Incision of Infection when used with antibiotic therapy; Excision & Ablation of lesions, benign & malignant lesions, oral cavity turnors, and hemangiomas; Salivary Gland Pathologies; Preprosthetic Gum Preparation, Leukoplakia; Partial Glossectomy; Periodontial Gum Resection; Homeostasis; Operculectorny; Crown Lengthening (soft tissue). | Prescription Use _____________________________________________________________________________________________________________________________________________________________ | AND/OR | Over-The-Counter Use | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|------------------------|--| | (Part 21 CFR 801 Subpart D) | | (21 CFR 807 Subpart C) | | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) For NRO Atiq Chowdhury - 5 (Division Sign-Off) for BSA Division of Surgical Devices 510(k) Number _ K132661 Page 1 of __ 1_