DUAL SWITCH

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure in profile, with three faces overlapping to symbolize health, human services, and the relationship between them. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 22, 2014 Laser Engineering Incorporated Ms. Laurie Dobbs Management Representative 475 Metroplex Drive, Suite 401 Nashville, Tennessee 37211 Re: K141908 Trade/Device Name: Dual Switch Adapter 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: September 16, 2014 Received: September 22, 2014 Dear Ms. Dobbs: 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 {1}------------------------------------------------ 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # David Krause -S - for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K141908 Device Name Dual Switch Adapter #### Indications for Use (Describe) The intended use for the Dual Switch Adapter is for the vaporization, ablation, or photocaogulation of soft tissue in the surgical specialties of ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry. The intended use of the Dual Switch Adapter is for the performance of specific surgical applications in the surgical specialties of ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry as follows: Dermatology: The Dual Switch Adapter is indicated for use in dermatology and plastic surgery for the following applications: -Ablation, vaporization, excision, and coagulation of soft tissue in the performance of: laser skin resurfacing, laser dermabrasion, and laser burn debridement -Laser skin resurfacing) ablation and/or vaporization) for the treatment of: wrinkles, rhytids and furrows (including fine lines and texture irregularities). -Laser skin resurfacing (ablation, and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of. Keratosis, including actinic and sebortheic keratosis, seborrheci wart and verruUT sebortheica. Vermillionectomy of the lip Cutaneous horns Solar/actinic elastosis Cheilis, including actinic cheilitis Lentigines, including lentigo maligna or Hutchinson's malignant freckle Uneven pigmentation/dyschromia Acne scars Surgical scars Keloids including acne keloidalis nuchae Hemangiomas (including Buccal, port wine and pygenic granuloma pyogenicum/granuloma telangiectatioum) Tatoos Telangiectasia Removal of small skin tumors, including periungual (Koenen) and subungual fibromas Superficial pigmented lesions Adenosebaceous hypertrophy or sebaceous hyperplasia Rhinophyma reduction Cutaneous papilloma (skin tags) Milia Debridement of eczematous or infected skin Bramous and squamous cell carminoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions Nevi, including spider, epidermal, and protruding Neurofibromas Laser de-epitheliazation Tricoepitheliomas Xanthelasma palpebrarum {3}------------------------------------------------ ## Syringoma -Laser ablation, vaporization, and/or excision for complete and partial nail matrixecomy - Vaporization/coagulation of: benign/malignant vascular skin lesions, Moh's surgery, Lipectomy, Verrucae and seborrhoecae vulgares, including paronychial, periungual and subungual warts -Laser incision and/or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty -Laser incision and/or excision of soft tissue for the creation of receipt sites for hair transplantation ## Podiatry The Dual Switch Adapter is indicated for use in podiatry for the following applications: -Laser ablation, vaporization, and/or excision of soft tissue for the reduction, removal, and/or treatment of: Verrucae vulgares/plantar (warts), including paronychial, periungual and subungual warts - Fungal nail treatment Porokeratoma ablation Ingrown nail treatment Neuromas/fibromas, including Morton's neuroma Debridement of ulcers Other soft tissue lesions -Laser ablation, vaporization, and/or excision for complete and partial (nail) matrixectomy ## Otolaryngology The Dual Switch Adapter is indicated for laser incision, ablation and/or vaporization of soft tissue in otolaryngology for the treatment of: -Choanal atresia -Leukoplakia, including oral, larynx, uvula, palatal, and upper lateral pharyngeal tissue -Nasal obstruction -Adult and juvenile papillomatosis polyps -Polypectomy of nose and nasal passages -Lymphangioma removal - -Removal of vocal cord/fold nodules, polyps and cysts -Removal of recurrent papillomas in the oral cavity, nasal cavity, larynx and trachea, including the uvula, palatal. upper lateral pharyngeal tissue, tongue and vocal cords. -Laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue -Zenker's Deverticulum/pharyngoesophageal diverticulum) endoscopic laser-assisted esophagodiverticulostomy (ELAED) -Stenosis, including subgottic stenosis Tonsillectomy (including tonsilar cryptolysis and neoplasma) and tonsil ablation/tonsillotomy -Pulmonary bronchial and tracheal lesion removal -Benign and malignant nodules, tumors and fibromas (larynx, trachea, tracheobronchial/endobronchial) -Benign and malignant lesions and fibromas (nose and nasal passages) -Benign and malignant tumors and fibromas (oral) -Stapedotomy/Stapedectomy -Acoustic neuroma in the ear -Superficial lesions of the ear, including chondrodermatatis nondularis chroniUT helices/Winkler's disease -Telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal, or upper lateral pharyngeal tissue) -Cordectomy, cordotomy (for the treatment of vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea -Myringotomy/tympanostomy (tympanic membrane fenestration) -Uvulopalatoplasty and turbinate reduction/ablation -Septal spur ablation/reduction and septoplasty -Partial glossectomy - -Tumor resection of oral, subfacial and neck tissue -Rhinophyma -Verrucae vulgares (warts) {4}------------------------------------------------ -Gingivoplasty/gingivectomy Gynecology and GYN Laparoscopy Indication The Dual Switch Adapter is indicated for use in gynecology for the following applications: -Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of: Conization of the cervix, including cervical intraepithelial neoplasia (CIN), and vulvar and vaginal intraepithelial neoplasia (VIN, VAIN) Condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowenoid papulosa (BP lesions) Leukoplakia (vulvar dystrophies) Incision and drainage (I&D) or Bartholin's and nabothian cysts Herpes vaporizaton Urethral caruncle vaporization Cervical dysplasia Benign and malignant tumors Hemangiomas - Vaporization, incision, excision, ablation or photocoagulation of soft tissue in endoscopic surgery, including gynecological laparoscopy, for the treatment of: Endometrial lesions, including ablation of endometriosis Excision/lysis adhesions Salpingostomy Oophorectomy Fimbrioplasty Metroplasty Microsurgery (tubal) Uterine myomas and fibroids Ovarian fibromas and follicle cysts Uterosacral ligament ablation Hysterectomy Neurosurgery Indications The Dual Switch Adapter is indicated for laser incision, ablation and/or vaporizaton of soft tissue in neurosurgery for the treatment of: -Cranial Posterior fossa tumors Peripheral neurectomy Benign and malignant tumors and cysts, for example, gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas, and large tumors Arteriovenous malformation Pituitary gland tumors (transphenoidal approach) -Spinal Cord Incision/excision and vaporization of benign and malignant tumors and cysts Intra and extradural lesions Laminectomy/laminotomy/microdiscectomy Orthopedic Indication The Dual Switch Adapter is indication, excision, and vaporization of soft tissue in orthopedic surgery, including the following applications: -Arthroscopy Meniscectomy Chondromalacia {5}------------------------------------------------ Chondroplasty Ligament release (lateral and other) Excision of plica Partial synovectomy -General Debridement of traumatic wounds Debridement of decubitus and diabetic ulcers Microsurgery Artificial joint revision PMMA removal General and Thoracic Surgery The Dual Switch Adapter is indication for the incision, and vaporization of soft tissue in general and thoracic surgery, including endoscopic and open procedures. Applications include: -Debridement of decubitus ulcers stasis, diabetic, and other ulcers -Mastectomy - -Debridement of burns - -Rectal and anal hemorrhoidectomy - -Breast biopsy - -Reduction mammoplasty - -Cytoreduction for metastatic disease - -Laparotomy and laparoscopic applications - -Mediastinal and thoracic lesions and abnormalities - -Skin tag vaporization - -Atheroma - -Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips - -Pilondial cyst removal and repair - -Abscesses - -Other soft tissue applications Dental and Oral Surgery The Dual Switch Adapter is indication for the incision, excision of soft tissue in dentisty and oral surgery. Applications include: - -Gingivectomy/removal of hyperplasias - -Gingivoplasty - -Incisional and excisional biopsy - -Treatment of ulcerous lesions, including aphthous ulcers - -Incision of infection when used with antibiotic therapy - -Frenectomy (frenum release) - -Excision and ablation of benign and malignant lesions - -Homeostasis - -Operculectomy - -Crown lengthening - -Removal of soft tissue, cysts and tumors - -Oral cavity tumors and hemangiomas - -Abscesses - -Extraction site hemostasis - -Salivary gland pathologies - -Preproshetic gum preperation - -Leukoplakia {6}------------------------------------------------ Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {7}------------------------------------------------ # SECTION 7- 510(K) SUMMARY # Applicant: Laser Engineering 475 Metroplex Drive Suite 401 Nashville, TN 37211 Tel: (615) 550-8282 Contact Person: Laurie Dobbs Management Representative I.dobbs@americansurg.com Date Prepared: May 27, 2014 # Device Name: Dual Switch Adaptor Proprietary Name: Classification Name: Classification: Product Code: Dual Switch Adaptor Laser Surgical Instrument 878.4810 GEX ## Predicate Devices: The Dual Switch Adaptor is substantially equivalent to the following devices. | Device | Manufacturer | 510(k) No. | |---------------------------------------|--------------|------------| | AcuPulse Duo<br>40WG CO2 Laser System | Lumenis | K100415 | {8}------------------------------------------------ The Dual Switch Adaptor is an accessory that can be mounted onto the Ultra MD CO2 Laser System currently manufactured by Laser Engineering, Inc. under the existing 510K numbers: K881580, K881581, K881582, K881583, K881584, K881585, K881587, K881588, and K905676. The Dual Switch Adaptor allows the laser beam to exit the laser vertically through the articulating arm or horizontally through a flexible laser waveguide. The Dual Switch Adaptor provides an alternate 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 Dual Switch Adaptor consists of a protective housing that is mounted into the path of the laser beam to divert the energy to the fiber coupler. The Dual Switch Adaptor is designed to operate at 10.6um and has a broad enough transmission band to accommodate any laser operating in this region. The laser energy can be supplied traditionally through the articulating arm or into a focusing lens that is coupled into the flexible waveguide, exiting to the tissue at the distal end. #### Indications for Use: The Dual Switch Adaptor is indicated for use with the Ultra MD CO2 Laser Systems for general and plastic surgery procedures, neurosurgery, and ophthalmology, oral surgery, oto-rhinolaryngology, podiatry, gynecology and urology procedures. It is used to deliver laser energy for incision, excision, ablation, vaporization, and coagulation of soft tissues. The Dual Switch Adaptor can be used in open surgical procedures and endoscopic procedures. The use of the Dual Switch Adaptor does not change the indications for use of the Ultra MD CO2 laser system. {9}------------------------------------------------ # 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 Dual Switch Adaptor is substantially equivalent to existing legally marketed devices. ## Performance testing: The Dual Switch Adaptor is bench tested to establish percent transmission, optical alignment and alignment stability