MEDART DIODE LASER SYSTEM & ACCESSORIES

{0}------------------------------------------------ K115243 Page U + U Image /page/0/Picture/1 description: The image shows the logo for "MedArt", with the tagline "an ENERGIST - Group Company" underneath. The word "MedArt" is written in a bold, stylized font, with the letters "M", "e", and "d" appearing to have a textured or outlined effect, while the letters "A", "r", and "t" are solid black. The tagline is in a smaller, simpler font, centered below the main logo. # 5. 510 (k) Summary (21 CFR 807.92) | 510 (k) Submitter's Name: | MedArt A/S | |------------------------------------|------------------------------------------------------------------------------------------------------| | Address: | MEDART A/S Industriholmen 15a Hvidovre, Denmark DK-2650 | | Contact Person: | Joanne Davies, Regulatory Affairs Manager, Energist Limited joanne.davies@energist-international.com | | Telephone: | +44(0)1792 798768 | | Fax: | +44(0)1792 762099 | | Date: | 20 ^th January 2010 | | Device Name: | MedArt® 720 | | Trade/Proprietary Name: | MedArt® Diode Laser System & Accessories | | Classification Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology | | Confidentiality Preference: | No preference | | Establishment Registration Number: | 8021543 | | 510 (K) Type: | Traditional | | Class: | 2 | | Panel: | General & Plastic Surgery | | Product Code: | GEX | | Submission Basis: | New Device | | Description of Device: | | {1}------------------------------------------------ 11043 page (2) of (4) Image /page/1/Picture/1 description: The image shows the logo for MedArt, with the words "MedArt" in a stylized font. The first three letters, "Med", are in a lighter color and have a textured, almost sketched appearance, while the last three letters, "Art", are in a solid, darker color. Below the logo, in smaller font, it says "an ENERGIST * Group Company". The MedArt® 720 laser unit is a Class 4 laser that emits invisible laser radiation. The unit is fed by a diode laser module providing continuous or pulsed wave laser beam operating at a wavelength of 980 nm that is primarily absorbed in melanin, haemoglobin and dark tissue. A limited amount of light is absorbed by water enabling fast increase in irradiated areas leading to effective heating of tissue at low power outputs. ### Intended Use: The MedArt 720 Diode Laser System & Accessories is a prescription only device intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The MedArt 720 Diode Laser System & Accessories is generally indicated for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, and cardiothoracic surgery and ophthalmology. The MedArt 720 Diode Laser System & Accessories is specifically indicated for laser assisted lipolysis | Ear Nose, Throat &<br>Oral Surgery | Hemostasis, incision, excision, ablation, coagulation &<br>vaporization of tissue from the ear, nose, throat & adjacent<br>areas including soft tissue in the oral cavity. | |-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Dental Applications | Intraoral and extra-oral soft tissue (including marginal and<br>interdental gingiva and epithelial lining of free gingiva | | Arthroscopy | Hemostasis, incision, excision, coagulation, vaporization and<br>ablation of joint tissues during arthroscopic surgery | | Gastroenterology | Hemostasis, incision, excision, ablation, coagulation &<br>vaporization of tissue in the upper and lower<br>gastrointestinal tracts and also with endoscopic procedures | | General surgery,<br>Dermatology,<br>Plastic Surgery &<br>Podiatry | Excision, ablation, vaporization and photocoagulation of<br>skin lesions, hemostasis, incision, excision, vaporization,<br>ablation and debulking of soft tissue, abdominal, rectal,<br>skin, fat or muscle tissue and dermabrasion | | Urology | Excision, vaporization, incision, coagulation, ablation and<br>hemostasis of urological tissues | | Gynecology | Ablation, excision, incision, coagulation, hemostasis and<br>vaporization of gynecological tissue | #### Indications For Use: {2}------------------------------------------------ K110243 : " " Page 3 of 4 Image /page/2/Picture/2 description: The image shows the logo for MedArt, which is written in a stylized font. Below the company name, it says "an ENERCIST Group Company". The text is black and white. | Neurosurgery | Vaporization, coagulation, excision, incision ablation and hemostasis of soft tissue | |-----------------------------|------------------------------------------------------------------------------------------------------------------| | Pulmonary Surgery | Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system | | Cardiothoraic<br>Surgery | Incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissue including cardiac tissues | | Laser Assisted<br>Lipolysis | Laser Assisted Lipolysis | | Opthalmology | The ablation, vaporization, excision, incision, and coagulation of soft tissue in opthalmology | {3}------------------------------------------------ 11/0243 . : Page (4) of (4) Image /page/3/Picture/2 description: The image shows the logo for MedArt, which is written in a stylized font. Below the logo, it says "an ENERGIST • Group Company". The logo is black and white and appears to be slightly pixelated. # Predicate Device: K081015 # Technological Characteristic Comparison | Characteristic | MedArt® 720 | Cerelas D980 | Cerelas D980 | |------------------|----------------------|---------------|----------------| | 510 (k) | K110243 | K081015 | K081015 | | CFR | 878.4810 | 878.4810 | 878.4810 | | Laser Class | 4 | 4 | 4 | | Laser Wavelength | 980 nm +/- 10 nm | 980 nm | 980 nm | | Output Power | 15W | 15W | 25W | | Size | 10.9" x 13.0" x 6.0" | 7" x 9" x 14" | 7" x 15" x 16" | | | II | II | II | | Product Code | GEX | GEX | GEX | - This summary only includes information that is covered in the body of the 510 (k) . - Ths summary does not contain any unsubstantiated labeling claims o - This summary includes summary data only ● - This summary does not contain any trade secrets or confidential commercial o information - The summary does not contain any patient identifiction information � {4}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure embracing or protecting another, conveying a sense of care and support. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 MedArt A/S % Energist, Ltd. Ms. Joanne Davies Clos Llyn Cwm Swansea, Wales United Kingdom SA6 8QY JUN 2 8 2011 Re: K110243 Trade/Device Name: MedArt® 720 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: June 16, 2011 Received: June 21, 2011 Dear Ms. Davies: 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. {5}------------------------------------------------ Page 2 - Ms. Joanne Davies 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/ResourcesforYou/Industry/default.htm. Sincerely yours, Ernst Keith - Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ K1||0243 Page① of ② Image /page/6/Picture/1 description: The image shows the logo for MedArt, with the words "MedArt" in a stylized font. Below the company name, in a smaller font, it says "an ENERGIST • Group Company". The logo is simple and professional, and the text is easy to read. 4. Indications for Use Statement 510{k} Number (if known): Device Name: MedArt® 720 Intended Use: (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K110243 The MedArt 720 Diode Laser System & Accessories is a prescription only device intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The MedArt 720 Diode Laser System & Accessories is generally indicated for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, and cardiothoracic surgery and ophthalmology. The MedArt 720 Diode Laser System & Accessories is specifically indicated for laser assisted lipolysis | Ear Nose, Throat &<br>Oral Surgery | Hemostasis, incision, excision, ablation, coagulation &<br>vaporization of tissue from the ear, nose, throat & adjacent<br>areas including soft tissue in the oral cavity. | |-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Dental Applications | Intraoral and extra-oral soft tissue (including marginal and<br>interdental gingiva and epithelial lining of free gingiva | | Arthroscopy | Hemostasis, incision, excision, coagulation, vaporization and<br>ablation of joint tissues during arthroscopic surgery | | Gastroenterology | Hemostasis, incision, excision, ablation, coagulation &<br>vaporization of tissue in the upper and lower gastrointestinal<br>tracts and also with endoscopic procedures | | General surgery,<br>Dermatology,<br>Plastic Surgery &<br>Podiatry | Excision, ablation, vaporization and photocoagulation of skin<br>lesions, hemostasis, incision, excision, vaporization, ablation<br>and debulking of soft tissue, abdominal, rectal, skin, fat or<br>muscle tissue and dermabrasion | | Urology | Excision, vaporization, incision, coagulation, ablation and<br>hemostasis of urological tissues | | Gynecology | Ablation, excision, incision, coagulation, hemostasis and<br>vaporization of gynecological tissue | | Neurosurgery | Vaporization, coagulation, excision, incision ablation and | ### Indications for Use: Industriholmen 15A DK-2650 Hvidovre Denmark {7}------------------------------------------------ K110243 Page (2) of (2) Image /page/7/Picture/2 description: The image shows the logo for MedArt, with the words "MedArt" in large, bold letters. Below the logo, in smaller letters, it says "an ENERGIST Group Company". The logo is simple and professional, and the text is clear and easy to read. | | hemostasis of soft tissue | |-----------------------------|---------------------------------------------------------------------------------------------------------------------| | Pulmonary Surgery | Hemostasis, vaporization, coagulation, incision, excision and<br>ablation of soft tissue in the pulmonary system | | Cardiothoracic<br>Surgery | Incision, excision, vaporization, ablation, hemostasis, and<br>coagulation of soft tissue including cardiac tissues | | Laser Assisted<br>Lipolysis | Laser Assisted Lipolysis | | Opthalmology | The ablation, vaporization, excision, incision, and coagulation<br>of soft tissue in opthalmology | 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) Page 1/1 Neil RP Oshn for mkm Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K110243 Industriholmen 15A DK-2650 Hvidovre Denmark