ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE

{0}------------------------------------------------ OCT 2 1 2011 : # SECTION 5 - 510(K) SUMMARY ### Applicant: K112166 રુદ્યા બ ૩ W and R Investments, LLC d/b/a Laser Engineering 113 Cedar Street Suite S5 Milford, MA 01757 Tel: (508) 520-2552 Contact Person: Robert I. Rudko, Ph.D. Chief Scientist rrudko@laserengineering.com Date Prepared: July 19, 2011 #### Device Name: CO2 Laser Waveguide Proprietary Name: Classification Name: Classification: Product Code: UltraLase Flexible CO2 Laser Waveguide Laser Surgical Instrument 878.4810 GEX #### Predicate Devices: The UltraLase Flexible CO2 Laser Waveguide is substantially equivalent to the following devices: | Device | Manufacturer | 510(k) No. | |---------------------------------------------|-----------------|------------| | FiberLase CO2 Laser Waveguide | Lumenis Ltd | K100384 | | SureGuide CO2 Laser<br>Beam Delivery System | Clinicon Corp. | K992472 | | Beam Path CO2 Mark III<br>WaveGuide Fiber | OmniGuide, Inc. | K070157 | {1}------------------------------------------------ K112166 Pg 2 of 3 #### Device Description: The UltraLase Flexible CO2 Laser Waveguide is a laser delivery system for use in surgical procedures where a flexible delivery system would allow easier and more efficient delivery of laser energy to the targeted tissue. The waveguide consists of a flexible silica capillary whose inside wall has been coated with a durable coating that is highly reflective at the intended wavelength of use. A fiber optic connector is attached to the proximal end of the waveguide and the waveguide is covered with a plastic sleeve for protection. The UltraLase Flexible CO2 Laser Waveguide is supplied with a single use handpiece attached or without a handpiece so it can be used with various reusable handpieces such as the TTI Medical ACCU-Beam Fiberoptic Handpieces. The UltraLase Flexible CO2 Laser Waveguide is designed to operate at 10.6µm and has a broad enough transmission band to accommodate any laser operating in this region. The laser energy is coupled into the waveguide using the supplied focusing lens and travels down the waveguide by multiple bounces off the inner reflective surface, exiting to the tissue at the distal end. The UltraLase Flexible CO2 Laser Waveguides come with either a 905 SMA connector or a 953 ST connector and are therefore can be used with any CO2 Laser that is compatible with one of these connectors. The waveguide is supplied in several diameters and lengths as shown in the following chart. | Core Dia. (µm) | Outer Dia. (µm) | Lengths (cm) | |----------------|-----------------|---------------| | 300 | 750 | 100, 150 | | 500 | 850 | 100, 150, 200 | | 750 | 1200 | 100, 150, 200 | It is recommended that a purge gas system using an inert gas such as helium be used to force an inert gas through the waveguide for cooling and to keep the inner channel of the waveguide free of debris. The waveguides delivery systems are supplied sterile for single use. {2}------------------------------------------------ K112166 pg 3 of 3 #### Indications for Use: The UltraLase Flexible CO2Laser Waveguide is indicated for use with CO2 laser systems for general and plastic surgery procedures neurosurgery, ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, gynecology and urology procedures. It is used to deliver laser energy for incision, excision, ablation, vaporization, and coagulation of soft tissues. The UltraLase Flexible CO2 Laser Waveguide can be used in open surgical procedures and endoscopic procedures. The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached. ## Technological Characteristics Compared to Predicate Device: After reviewing the technological characteristics (overall design, mechanism of action, mode of operation and performance characteristics) and the indications for use, it has been determined by Laser Engineering that the UltraLase Flexible CO2 Laser Waveguide is substantially equivalent to existing legally marketed devices. ### Performance testing: The UltraLase Flexible CO2 Laser Waveguides are bench tested to establish transmission bandwidth, and percent transmission. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes, positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The text is arranged in a circular fashion around the bird-like figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 OCT 2 1 2011 W and R Investments, LLC d/b/a Laser Engineering % Robert I. Rudko, Ph.D. 113 Cedar Street, Suite S5 Milford, Massachusetts 01757 Re: K112166 Trade/Device Name: UltraLase Flexible CO2 Laser Waveguide 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: July 19, 2011 Received: July 28, 2011 Dear Dr. Rudko: 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 Foond, Or ug, 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 contractly and warranties. We remind you; however, that device labeling must be truth to bond not misleding. 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. {4}------------------------------------------------ Page 2 - Robert I. Rudko, Ph.D. 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 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/CDRH/CDRHOffices/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 vours, Erin Keith forMark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # SECTION 4 - INDICATIONS FOR USE STATEMENT K112166 510(k) Number: UltraLase Flexible CO2 Laser Waveguide Device Name: Indications for Use: The UltraLase Flexible CO2Laser Waveguide is indicated for use with CO2 laser systems for general and plastic surgery procedures, neurosurgery, and ophthaimology, oral surgery, oto-rhino-laryngology, podiatry, gynecology and urology procedures. It is used to deliver laser energy for incision, excision, ablation, vaporization, and coagulation of soft tissues. The UltraLase Flexible CO2Laser Waveguide can be used in open surgical procedures and endoscopic procedures. The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached. Over-The-Counter Use Prescription Use x Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) a management and consistence and the manufactures and the commended the seasonal commended the sense comments of Concurrence of CDRH, Office of Device Evaluation (ODE) E.M. Kuth (Division Sign-Off) Division of Surgical " it bedie, and Restorative Device 510(k) Number K112166