NOVEON, MODEL LS1100-01-0968

{0}------------------------------------------------ Nomir Noveon™ (Model LS1100-01-0968)- 510(k) Summary K071815 # 510(k) Summary ### Noveon™ (Model LS1100-01-0968) Dual Wavelength Laser Instrument 【日本】【KITC ミニー " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " November 19, 2007 #### Submittal information: Post-approval contact: Richard Burtt Chief Executive Officer Nomir Medical Technologies 275 Grove Street, Suite 2-400 Newton, MA 02466 Phone: 617-901-6637 Fax: 617-663-4801 NOV 2 8 2007 #### Device name and classification 510(k) Number: K071815 Proprietary Name: Noveon™ (Model LS1100-01-0968) Common Name: Medical Diode Laser Classification Name: Class IV Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology Classification Panel: General and Plastic Surgery Devices CFR Section: 21 CFR 870.4810 Class: II Product Code: GEX #### Predicate Devices - Ceralas D 810 Diode Laser System, K032864, by Biolitec, Inc . - LaserPro 810, 940, and 980 Dioxide Laser Systems, K040294, by Photomedex, Inc . - . Vectra Laser System, K060114, by Xintec Corporation - . BWF-5 Medical Laser Series, K062363, by B&W Tek Inc - PhoTex15 Diode Laser Series: 980, 810, 940, K060304, by BioTex Inc . - Q YAG 5 Nd: YAG Laser System, K061436, by Palomar Medical Technologies, Inc . - . Medlite C3 Q Switched Nd: YAG Laser, K011677, by Continuum Electro-Optics, Inc (now Hoya ConBio, Inc) #### Device Description The Noveon™ (Model LS1100-01-0968) is a Class IV Laser Surgical Instrument for use in General and Plastic Surgery and Dermatology. The device consists of the following components and accessories: - 1. Laser Source and Control Unit: Two Class IV laser diodes, each providing continuous-wave laser light, one at the 870 mm and one at 930 nm wavelength. The power output of each laser is selectable from 1W to 8W in 0.1 W increments. There are two touch sensitive screens to control the optical power output of each laser and a separate emergency on/off button. - 2. Foot Pedal Switch: turns the lasers on/off when the lasers are enabled. ### Confidential and Proprietary to Nomir Medical Technologies {1}------------------------------------------------ - 3. Flexible Optical Fiber and End Piece: designed to be lightweight for holding the distal end of the fiber comfortably in the hand to perform procedures. #### Intended Use The Noveon™ (Model LS1100-01-0968) delivers continuous wave laser light in the contact or non-contact mode during surgical procedures of the skin, subcutaneous tissues and nasal passages in dermatology, plastic surgery, podiatry and otolaryngology. The device is indicated for use in applications requiring incision, excision, vaporization, hemostasis, or coagulation of soft tissue. #### Performance Data #### Performance Standards - The Noveon™ (Model LS1100-01-0968) complies with applicable performance standards . for light emitting products as outlined in 21 CFR 1040.10 and 21 CFR 1040.11. - . The device has been tested and verified by Intertek ETI Semko as conforming to 47 CFR Part 15, Subpart B Unintentional Radiator Class A. Prior to introduction into the US market, the device will be tested and verified to conform to the applicable voluntary electrical equipment standards; IEC 60601-1, IEC 60601-1-1, and IEC 60601-1-2. - The device also conforms to the standards for biocompatibility as given by Cytoxicity: ISO ● 10993-5, Sensitization: ISO 10993-10, and Irritation: ISO 10993-10. #### Performance Testing A surgical study with a live Yorkshire pig was conducted to test the capability of the Noveon™ (Model LS1100-01-0968) to perform incision, contact coagulation, non-contact coagulation, debridement, curettage and excision. Results from this study demonstrate the device satisfactorily performed these procedures when used by a medical professional. Importantly, there were no adverse events that were noted during the performance of any of these demonstrations. Altogether there were 130 passes of the laser made during this demonstration, of which 127 were made in the contact mode: incision (5), contact coagulation (4), debridement (19), curettage (31), and excision (68). Using tissue samples of porcine skin, muscle, and liver we tested individual samples with exposures to 940 nm, 930 nm, and 870 nm. In addition, we tested samples with 870 nm and 930 nm in three different optical power combinations. The testing included both contact and noncontact (free beam) mode. The testing was performed in triplicate. For each test the width and depth of the zone of ablation, the zone of coagulation (necrosis) and the zone of total destruction were recorded. These data substantiate that the difference in tissue effect was comparable to the 940 nm predicate device and any differences were not of clinical significance. #### Substantial Equivalence The Noveon™ (Model LS1100-01-0968) share the same indications for use, similar laser and electronics design features, safety and functional features, and therefore are substantially equivalent to the predicate devices listed above. #### Safety and Effectiveness The Noveon™ (Model LS1100-01-0968) is designed in accordance with both mandatory and voluntary Standards ensuring it is both safe and effective for the medical procedures indicated above. No new clinical indications are to be provided by the introduction of the device as compared to the predicate devices, identified above, which have previously demonstrated clinical effectiveness. ## Confidential and Proprietary to Nomir Medical Technologies {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circular pattern around the bird. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 2 8 2007 Nomir Medical Technologies, Inc % Richard Burtt Chief Executive Officer 275 Grove Street, Suite 2-400 Newton, Massachusetts 02466 Re: K071815 Trade/Device Name: Noveon™ Model LS1100-01-0968 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: November 19, 2007 Received: November 20, 2007 Dear Mr.Burtt: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. {3}------------------------------------------------ #### Page 2 -- Mr. Richard Burtt This letter will allow you to begin marketing your device as described in your Section 510(k) r ms leter witification. The FDA finding of substantial equivalence of your device to a legally premaince noticate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to ( premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours, Mark N Mulhearn Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### Indications for Use Statement L1 510(k) Number (if known): K071815 Device Name: Noveon™ (Model LS1100-01-0968) Indications For Use: The Noveon™ (Model LS1100-01-0968) delivers continuous wave laser light in the contact or non-contact mode during surgical procedures of the skin, subcutaneous tissues and nasal passages in dermatology, plastic surgery, podiatry and otolaryngology. The device is indicated for use in applications requiring incision, excision, vaporization, hemostasis, or coagulation of soft tissue. Rih (Division Sig-Off) Division of General, Restorative, and Neurological Devices **510(k) Numbe**r: 2601818 Prescription Use X AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)