EdgeOne CO2 Laser

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, layered on top of each other. The profiles are depicted in a simple, flowing line style. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 27, 2016 Jeisys Medical Inc. % Kathy Maynor Consultant Ronyam Enterprises LLC 26 Rebecca Ct Homosassa, Florida 34446 Re: K162169 Trade/Device Name: EdgeOne CO2 Laser 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. ONG Dated: July 30, 2016 Received: August 3, 2016 Dear Ms. Maynor: 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 {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Jennifer R. Stevenson -A 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) K162169 Device Name Jeisys EdgeOne CO2 Laser # Indications for Use (Describe) It is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology(ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing. Type of Use (Select one or both, as applicable) | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------| | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ #### I. General Information | Submitter: | JEISYS MEDICAL INC.<br>307 Daeryung Techno Town 8th<br>481-11, Gasan-Dong, Geumcheon-Gu<br>Seoul Seoul Teugbyeolsi, KOREA, REPUBLIC<br>OF 153-775 | |------------|---------------------------------------------------------------------------------------------------------------------------------------------------| |------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Kathy Maynor | | |---------------------------|---------------------|--| | | Consultant | | | | 352-586-3113 (cell) | | | Summary Preparation Date: | July 29, 2016 | | #### II. Names | Device Names: | The Jeisys EdgeOne CO2 Laser | |-------------------------------|------------------------------------| | Primary Classification Names: | Surgical Powered Light Instrument, | #### III. Predicate Devices | K # | Predicate Device | |---------|-----------------------------| | K100590 | EDGE CO2 LASER SYSTEM | | K133895 | DEKA SMARTXIDE LASER SYSTEM | #### IV. Product Description The Jeisys EdgeOne CO2 Laser is comprised of the following major components: - 1. The main console unit - 2. Delivery handpieces (2 surgical and one fractional) - 3. Footswitch. - Accessories 4. ### V. Indications for Use It is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology(ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery {4}------------------------------------------------ (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing. ## VI. Summary of Technical Characteristics | Parameter | K16XXX<br>Jeisys Edge One Laser | K100590<br>Jeisys Edge One Laser<br>(Predicate Device) | K133895<br>Deka Smartxide 2<br>(Secondary Predicate) | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code &<br>Regulation No. | GEX, ONG<br>21 CFR 878.4810 | GEX<br>21 CFR 878.4810 | GEX<br>21 CFR 878.4810 | | Laser Type | CO2 | CO2 | CO2 | | Laser wavelength | 10.6µm | 10.6µm | 10.6µm | | Output power | 30W | 30W | 60W | | Pulse Duration | 1-1000ms | 1-1000ms | 100 ~2,000 µs | | Fractional Pulse<br>energy | 1-300mJ | 1-300mJ | Unknown | | Repetition rate | 10-500Hz | 10-500Hz | 5Hz to 100Hz | | Scan area | 15 x 15mm2 | 15 x 15mm2 | 15 x 15mm | | Spot size (fractional) | 120um, 350um, 800um | 120um, 350um, 800um | 125µm, 155µm, 267µm,<br>325μm, 489µm, 530μm | | Surgical handpieces | 0,15, 1 | NA | 0.15, 1, collimated,<br>dental | | Operational mode | Fractional mode, normal<br>mode (CW, Pulse, Single<br>Pulse, Repeat, Group<br>pulse, Ultra) | Fractional mode, normal<br>mode (CW, Pulse, Single<br>Pulse, Repeat, Group<br>pulse, Ultra) | Fractional CW, SP, DP,<br>HP, UP<br>Normal<br>Interlaced<br>SmartTrack | | Aiming beam | Diode laser(Red) 655 +/-<br>10nm, Max 1mW | Diode laser(Red) 655 +/-<br>10nm, Max 1mW | Diode laser (Red) 635nm,<br>4mW max | | Fractional | Spot density 0-42.4% | Spot density 0-42.4% | Unknown | | Cooling | Water | Water | Water | | User Interface | LCD touch screen | LCD touch screen | LCD touch screen | | Optical guide | Articulated arm | Articulated arm | Articulated arm | | Electrical<br>Requirements | 230V~, 50/60Hz,<br>500VA(max. laser<br>output), 100 VA(stand-<br>by) | 230V~, 50/60Hz,<br>500VA(max. laser<br>output), 100 VA(stand-<br>by) | 100-120V~/220-230V~,<br>50/60Hz, 1600VA | | Indications for Use | It is indicated for<br>incision, excision,<br>ablation, vaporization and<br>coagulation of body soft<br>tissues in medical<br>specialties including<br>aesthetic (dermatology<br>and plastic surgery),<br>podiatry,<br>otolaryngology(ENT),<br>gynaecology,<br>neurosurgery,<br>orthopaedics, general and<br>thoracic surgery<br>(including open and<br>endoscopic), dental and<br>oral surgery and<br>genitourinary surgery.<br>The use with the scanning<br>unit is indicated for<br>ablative skin resurfacing. | The Edge CO 2 laser<br>when used in traditional<br>non-fractionated scanner<br>mode is<br>indicated for incision,<br>excision, ablation,<br>vaporization, and<br>coagulation of body soft<br>tissues.<br>The Edge CO 2 laser<br>when used in<br>fractionated mode is<br>indicated for ablative<br>skin<br>resurfacing. | It is indicated for<br>incision, excision,<br>ablation, vaporization<br>and coagulation of body<br>soft tissues in medical<br>specialties including<br>aesthetic (dermatology<br>and plastic surgery),<br>podiatry,<br>otolaryngology(ENT),<br>gynaecology,<br>neurosurgery,<br>orthopaedics, general<br>and thoracic surgery<br>(including open and<br>endoscopic), dental and<br>oral surgery and<br>genitourinary surgery.<br>The use with the<br>scanning unit is indicated<br>for ablative skin<br>resurfacing. | Table 1: Salient Characteristics of the Jeisys EdgeOne CO2 Laser and the Predicate Devices {5}------------------------------------------------ ### VII. Safety and Effectiveness Information The review of the indications for use and technical characteristics provided demonstrates that the Jeisys EdgeOne CO2 laser is substantially equivalent to the predicate devices. Product testing performed included: IEC 60601-1:2005 + CORR.1 (2006) + CORR.2 (2007) Medical electrical equipment – General Requirements for Electrical Safety - NO DEVIATIONS IEC 60601-2-22:2007 (Third Edition) + A1 (2012) for use with IEC 60601-1:2005 + A1 (2012) Medical Electrical Equipment - Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment IEC60601-1-2:2007 - Section 6, not life-supporting equipment, group 1&2, Class A - Medical Electrical Equipment PART 1: GENERAL REQUIREMENTS FOR SAFETY 2. COLLATERAL STANDARD: ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS AND TESTS {6}------------------------------------------------ ## VIII. Conclusion The Jeisys EdgeOne CO2 laser was found to be substantially equivalent to the predicate devices. The Jeisys EdgeOne CO2 laser shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate devices.