Fractional CO2 Surgical Laser System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. BraunSolutions % Mr. Alexander Henderson Official Correspondent 970 South Dawson Way Unit 14 Aurora, Colorado 80012-3827 Re: K173359 Trade/Device Name: BIOXEL Fractional CO2 Surgical Laser System 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: June 1, 2018 Received: June 5, 2018 Dear Mr. Henderson: 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 Actinclude 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device {1}------------------------------------------------ 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. 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@)fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. 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) K173359 Device Name BIOXEL CO2 Surgical Laser System #### Indications for Use (Describe) The BIOXEL CO2 Surgical Laser System is indicated for use, in the non-fractionated mode, for Incision, Excision, Ablation, Vaporization, and Coagulation of Human Body Soft Tissues. The system is intended for use in Dermatology, Plastic and General Surgery, Neurosurgery, and Podiatry. The BIOXEL CO2 Surgical Laser System is indicated for use, in the fractionated mode, for Ablative Skin Resurfacing, Wrinkle, Fine line, Rhylides, and Furrows in Dermatology. Type of Use (Select one or both, as applicable) | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | |-------------------------------------------------------------------------------------------------| | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | #### 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}------------------------------------------------ RM. 1412, SJ TECHNO VILLE, 278, BEOTKKOT-RO, GEUMCHEON-GU, SEOUL, KOREA TEL : 82-2-3281-9091 FAX : 82-2-3281-8011 E-MAIL : amimed@amimed.co.kr # EXECUTIVE SUMMARY #### 1. Name of Device Trade/Device Name: BIOXEL Fractional CO2 Surgical Laser System Regulation Number: 21CFR 878.4810 Regulation Name: Powered Laser Surgical Instrument Regulation Description: Laser Surgical instrument for use in general and plastic surgery and dermatology. Device Class: II Product Code: GEX #### 2. Predicate Devices K111831 MX-7000 MICROXEL, Dae Shin Enterprises K180036 SMAXEL, IDS, Ltd. ### 3. Prior Submissions Statement There were no prior submissions for the BIOXEL Fractional CO2 Surgical Laser System. ### 4. Device Description The BIOXEL CO2 Surgical Laser System is used in Dermatology, Plastic and General Surgery, Neurosurgery and Podiatry. This equipment consists of main body, Articulated Arm, hand-piece, protective goggles, foot switch and power cable. In a main body, there are a monitor displaying all information needed by an operator at a glance and a touch LCD screen, which facilitates operation of this equipment at user's convenience. The laser output is initiated with the foot switch. #### 5. Indications for Use The BIOXEL CO2 Surgical Laser System is indicated for use, in the non-fractional mode, for Incision, Excision, Ablation, Vaporization, and Coagulation of Human Body Soft Tissues. The system is intended for use in Dermatology, Plastic and General Surgery, Neurosurgery and Podiatry. The BIOXEL CO2 Surgical Laser System is indicated for use, in the fractional mode, for Ablative Skin Resurfacing, Wrinkle, Fine line, Rhylides, and Furrows in Dermatology. #### 6. Comparison Chart to Predicate Devices | Characteristics | BIOXEL (AMI, Inc.)<br>Subject Device | SMAXEL (IDS, Ltd.)<br>K180036 | MICROXEL (Dae Shin)<br>K111831 | |--------------------------|--------------------------------------|------------------------------------|------------------------------------| | Laser Wavelength | 10,600nm | 10,600nm | 10,600nm | | Laser Type | CO2 | CO2 | CO2 | | Maximum Power | 40W | 40W | 40W | | Laser Transfer<br>Method | Articulated Arm with hand<br>piece | Articulated Arm with<br>hand piece | Articulated Arm with<br>hand piece | | Dimensions(mm) | 440 x 480 x 1,830 | 420 x 410 x 920 | 420 x 410 x 1,120 | | Weight | 50 kgs | 50 kgs | 45 kgs | | Energy | 1-30 mJ | 5-30 mJ | 4-30 mJ | {4}------------------------------------------------ ### RM. 1412, SJ TECHNO VILLE, 278, BEOTKKOT-RO, GEUMCHEON-GU, SEOUL, KOREA TEL : 82-2-3281-9091 FAX : 82-2-3281-8011 E-MAIL : amimed@amimed.co.kr | Density | 1-23 Level | 1-23 Level | 1-23 Level | |------------|----------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------| | Scan Size | 20 x 20 mm | 20 x 20 mm | 5 x 15 mm | | Scan Shape | Square, Hexagonal,<br>Triangular, Circular | Square, Hexagonal,<br>Triangular, Circular | Square, Circle | | Mode | Fractional Mode<br>General (CW, Normal Pulse,<br>Super Pulse, Ultra Pulse) | General, Fractional, Non-<br>Factional, Low Power<br>Fractional | Fractional Mode<br>Normal Mode(CW, Super<br>Dream Pulse, Ultra<br>Dream Pulse) | | Off Time | 0.2 ~ 2.5 sec, Single | 0.5 ~ 2.5 sec, Single | 0.5 ~ 1.5 sec, Single | #### 8. Summary of Performance Testing The BIOXEL performs as intended based on performance data provided in the submission. Software: Verification and validation testing of the software confirm that the software version is appropriate for release. Electrical Safety and Electromagnetic Compatibility: The BIOXEL has been tested for electromagnetic compatibility and electrical safety per the applicable recognized consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22 and IEC 60825-1). Biocompatibility: Biocompatibility of the patient contacting components of the device has been established per ISO 10993-5. #### 9. Conclusion The BIOXEL CO2 Surgical Laser System was found to be substantially equivalent to the predicate devices. The BIOXEL CO2 Surgical Laser System shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate devices.