CO2 Laser System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. September 12, 2019 Feiying Drug & Medical Consulting Technical Service Group Becky Chen Registered Engineer B-3F 3005, Bldg. 1, Southward Ruifeng Business Center, No. 22 Guimiao Rd. Shenzhen, CN 518000 Guangdong Re: K191518 Trade/Device Name: CO2 Laser System (Model: GP900F) 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: August 15, 2019 Received: August 19, 2019 Dear Becky Chen: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Purva Pandya Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191518 Device Name CO2 Laser System (Model: GP900F) Indications for Use (Describe) The equipment is used for human tissue vaporization in dermatology, plastic surgery, and general surgery. The classical scanner is only for the treatment of wrinkles and skin resurfacing. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) | 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}------------------------------------------------ # 510 (k) Summary This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92. ## (1) Applicant information: | 510(k) owner's name: | SHENZHEN GSD TECH CO., LTD | |---------------------------|----------------------------------------------------------------------------------------------------------------------------| | Address: | BUILDING A JUNSD HI-TECH PARK, WEST OF<br>BAO'AN RD. WATCH & CLOCK BASE, GUANGMING<br>DISTRICT, SHENZHEN, GUANGDONG, CHINA | | Contact person: | Jiancheng zhang | | Phone number: | +86-13632740353 | | Fax number: | +86-0755-29109786 | | Email: | 535140627@qq.com | | Date of summary prepared: | 2019-09-11 | ## (2) Proprietary name of the device | Trade name/model: | CO2 Laser System (Model: GP900F) | |--------------------|----------------------------------------------------------------------------------------| | Common name: | Laser Surgical Instrument for Use In General And Plastic<br>Surgery And In Dermatology | | Regulation number: | 21CFR 878.4810 | | Product code: | GEX | | Review panel: | General & Plastic Surgery | | Regulation class: | II | ## (3) Predicate devices | | Primary Predicate | Reference Predicate | |----------------------|--------------------------------------------------------------------|---------------------| | Sponsor | Beijing Sincoheren Science and<br>Technology Development Co., Ltd. | Jeisys Medical Inc. | | Device<br>Name | CO2 Laser Therapy System | EdgeOne CO2 Laser | | 510(k)<br>Number | K162398 | K162169 | | Product<br>Code | GEX | GEX, ONG | | Regulation<br>Number | 21 CFR 878.4810 | 21 CFR 878.4810 | | Regulation | II | II | {4}------------------------------------------------ #### Class ## (4) Description/ Design of device: The subject device, CO2 Laser System (Model: GP900F) mainly consist of console, articulated arm and a foot switch. CO2 laser wavelength is 10600nm, which is used to gasify the skin tissue based on the principle of the theory selective photothermolysis. The water in skin absorbs laser energy and evaporates. By setting up the suitable energy and other parameters on skin tissue, the device can be used for human tissue vaporization and coagulation as well as for the treatment of wrinkles and skin resurfacing. ### (5) Intended use / Indications for use: The equipment is used for human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery. The classical scanner is only for the treatment of wrinkles and skin resurfacing. ### (6) Materials | Component name | Material of<br>Component | Body Contact<br>Category | Contact Duration | |-------------------------|--------------------------|--------------------------|--------------------| | Treatment hand<br>piece | Stainless steel 316L | Surface skin contact | Less than 24 hours | The treatment hand piece used in the CO2 Laser Systems has passed the Biocompatibility test. For details, please refer to "Biocompatibility Discussion". ## (7) Technological characteristics and substantial equivalence: | Item | Proposed device | Primary Predicate | Reference<br>Predicate | Remark | |----------------------|-------------------------------------|-----------------------------------------------------------------------------|------------------------|--------| | Trade name | CO2 Laser System<br>(Model: GP900F) | CO2 Laser Therapy<br>System | EdgeOne CO2<br>Laser | / | | Manufacturer | SHENZHEN GSD<br>CO., LTD | Beijing Sincoheren<br>Science and<br>Technology<br>Development Co.,<br>Ltd. | JEISYS<br>MEDICAL INC. | / | | 510 (k)<br>number | / | K162398 | K162169 | / | | Regulation<br>number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same | {5}------------------------------------------------ | Regulation<br>description | Laser surgical<br>instrument for use in<br>general and plastic<br>surgery and in<br>dermatology. | Laser surgical<br>instrument for use in<br>general and plastic<br>surgery and in<br>dermatology. | Laser surgical<br>instrument for use<br>in general and<br>plastic surgery and<br>in dermatology. | Same | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------| | Product<br>code | GEX | GEX | GEX | Same | | Class | II | II | II | Same | | Indications<br>for use/<br>Intended<br>use | The equipment is<br>used for human<br>tissue vaporization,<br>coagulation in<br>dermatology, plastic<br>surgery, and general<br>surgery. The<br>classical scanner is<br>only for the<br>treatment of<br>wrinkles and skin<br>resurfacing. | The equipment is<br>used for human<br>tissue vaporization,<br>coagulation in<br>dermatology, plastic<br>surgery, and general<br>surgery. The<br>fractional scanner is<br>only for the<br>treatment of<br>wrinkles and skin<br>resurfacing. | It is indicated for<br>incision, excision,<br>ablation,<br>vaporization and<br>coagulation of<br>body soft tissues in<br>medical specialties<br>including aesthetic<br>(dermatology and<br>plastic surgery),<br>podiatry,<br>otolaryngology(EN<br>T), gynaecology,<br>neurosurgery,<br>orthopaedics,<br>general and<br>thoracic surgery<br>(including open<br>and endoscopic),<br>dental and oral<br>surgery and<br>genitourinary<br>surgery. The use<br>with the scanning<br>unit is indicated for<br>ablative skin<br>resurfacing. | Same | | Location for<br>use | Prescription Use | Prescription Use | Prescription Use | Same | | Basic unit specifications | | | | | | Power<br>supply | 110-240VAC,<br>50-60Hz | 110-240VAC,<br>50-60Hz | 230V~, 50/60Hz | Same | | Dimensions | 480mm*380mm*10<br>53mm | 460mm×430mm×11<br>70mm | NA | Different<br>Note 1 | | Weight | 46kg | 65kg | NA | Different | | | | | | Note 1 | | Major<br>components | Console, articulated<br>arm and a foot<br>switch. | Console, articulated<br>arm and a foot<br>switch. | Main console unit,<br>articulated arm and<br>a foot switch. | Same | | Compliance<br>with<br>voluntary<br>standards | IEC 60601-1<br>IEC 60601-2-22<br>IEC 60825-1<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60825-1<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-2-22<br>IEC 60601-1-2 | Same | | Performance specification | | | | | | Output<br>Power<br>(Maximum) | 30W | 30W | 30W | Same | | Work Mode | Classical mode,<br>Surgical mode<br>(Single Pulse,<br>Continuous,<br>Muti-Pulse) | Scan (Single Pulse,<br>Continuous,<br>Muti-Pulse) | Fractional mode,<br>normal mode (CW,<br>Pulse, Single Pulse,<br>Repeat, Group<br>pulse, Ultra) | Same | | Laser<br>Medium/En<br>ergy Source | CO2 | CO2 | CO2 | Same | | CO2 Laser<br>Wavelength | 10600nm | 10600nm | 10600nm | Same | | Aiming<br>Beam<br>Wavelength | Red diode laser<br>650nm±10nm | Red diode laser 635<br>nm | Red diode laser<br>655 +/- 10nm | Similar<br>Note 2 | | Aiming<br>Beam<br>Power | < 5mW | < 5mW | NA | Same | | Spot Size<br>(Classical) | 0.5mm | 0.5mm | 120µm, 350µm,<br>800µm | Same | | Classical<br>Pulse<br>Energy | 0.1mJ~300mJ | 1mj-100mj is<br>optional for each dot | 1-300mJ | Same | | Pulse<br>Duration | Classical mode:<br>0.1ms~10ms<br>Surgical mode:<br>0.5ms~1000ms | NA | 1-1000ms | Same | | Repetition<br>rate | 10-500Hz | NA | 10-500Hz | Same | | Cooling | Air cooling | Air cooling | Water cooling | Same | | Control<br>System | Touch screen,<br>footswitch | Touch screen,<br>footswitch | Touch screen,<br>footswitch | Same | | Laser | Footswitch | Footswitch | Footswitch | Same | | Operation | | | | | | Patient<br>Contact<br>Sites | Skin | Skin | Skin | Same | | Biocompatibility | Passed the test as<br>per ISO 10993-5<br>and ISO 10993-10 | Passed the test as<br>per ISO 10993-5<br>and ISO 10993-10 | Passed the test as<br>per ISO 10993-5<br>and ISO 10993-10 | Same | | Electrical<br>Safety | Passed the test as<br>per IEC 60601-1<br>and IEC 60601-2-22 | Passed the test as<br>per IEC 60601-1 | Passed the test as<br>per IEC 60601-1<br>and IEC<br>60601-2-22 | Same | | EMC | Passed the test as<br>per IEC 60601-1-2 | Passed the test as<br>per IEC 60601-1-2 | Passed the test as<br>per IEC 60601-1-2 | Same | | Performance | Passed the test as<br>per IEC 60601-2-22<br>and IEC 60825-1 | Passed the test as<br>per IEC<br>60825-1 | Passed the test as<br>per IEC<br>60601-2-22 | Same | | Compliance<br>with 21CFR<br>898 | Yes | Yes | Yes | Same | | Sterility | Non-sterile | Non-sterile | Non-sterile | Same | {6}------------------------------------------------ {7}------------------------------------------------ ## Note 1: Although the appearance, weight and dimension are different between the target device, predicate devices, these differences are insignificant and do not adversely affect safety and effectiveness of the subject device compared to the predicate. ## Note 2: Similar aiming beam wavelength between the target device and predicate devices. The difference does not raise different questions of safety and effectiveness. ## Conclusion: CO2 Laser System (Model: GP900F) is substantial equivalent to the predicate device. ## (8) Non-clinical studies and tests performed: Non-clinical testing is conducted to verify that the CO2 Laser System meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the Proposed device complies with the following standards: - A IEC60601-1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance - A IEC 60601-2-22, Medical electrical equipment-Part2: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser {8}------------------------------------------------ equipment - > IEC 60825-1. Safety of Laser Products- Part 1: Equipment classification and requirements - > IEC60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests The body-contacting components of this device are the treatment head. The biocompatibility evaluation for the CO2 Laser Systems was conducted in accordance with the guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The treatment head is considered skin and subcutaneous tissue contacting for a duration of less than 24 hours. The biocompatible testing included In Vitro Cytotoxicity, Skin Sensitization and Intracutaneous Reactivity was conducted in compliance with: - A ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity - A ISO 10993-10, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization We have also conducted: - Software verification and validation test according to the requirements of the FDA A "Guidance for Pre Market Submissions and for Software Contained in Medical Devices". The software for this device was considered as a "moderate" level of concern. Software validation demonstrated that the software functions as specified in the software requirement specifications. - Bench performance testing to show that the device delivers set laser energy A parameters within specifications. ## (9) Conclusion Based on the above analysis and tests performed. it can be concluded that the subject device CO2 Laser System (Model: GP900F) is Substantially Equivalent (SE) to the predicate devices.