Diode Laser Therapy 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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. December 13, 2019 San He Lefis Electronics Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, 102401 Cn Re: K192569 Trade/Device Name: Diode Laser Therapy 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 Dated: September 16, 2019 Received: September 18, 2019 Dear Ray Wang: 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. 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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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192569 Device Name Diode Laser Therapy System Indications for Use (Describe) The Diode Laser Therapy System is intended for hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. | Type of Use (Select one or both, as applicable) | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span> <span style="padding-right: 20px;"> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92. The assigned 510(k) Number: K 1 9 2 5 6 9 - Date of Preparation 1. 09/16/2019 - Sponsor 2. ### San He Lefis Electronics Co., Ltd. No. 1 Production Room., ChaoBai Street, West Yiangbin Road, YanJiao Development Zone, Sanhe County, LangFang, HeBei Province, China 300000 Contact Person: Position: Ning Li Title: General Manager Assistant Tel: +86-18811392951 Fax: +86-316-3096027 Email: 1091118421@qq.com - 3. Submission Correspondent Mr. Ray Wang # Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401 Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com {4}------------------------------------------------ #### 4. Identification of Proposed Device Trade Name: Diode Laser Therapy System Common Name: Powered Laser Surgical Instrument Model(s): LFS-K8 Regulatory Information: Classification Name: Powered Laser Surgical Instrument Classification: II; Product Code: GEX ; Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery; Indication For Use: The Diode Laser Therapy System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. #### 5. Device Description The proposed device, Diode Laser, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI); #### Function module description a. Power System Power system including network power supply, laser power supply system, refrigeration power supply system and auxiliary power supply system, as shown in Fig 9-1. The power lines and rocker switch are used to control the on -off of hair removal instrument with the outside power supply. The key switch, emergency stop switch are used to control the on-off of network power, and then through the auxiliary power supply, provide the work current for the microprocessor control system, touch screen operation display system and other functional components, meanwhile, the on-off of power system for refrigeration and laser are realized by the pick-up and switching off of the relay that controlled by micro - processor. The power-on, energizing and the light emission process of main unit are subject to microprocessor control, in order to achieve controlling the hardware with software through microprocessor, so that the appliance operation are more stable and reliable. Laser power system adopt the power devices to constitute current regulation loop, thus can change the volume of output current through system regulation power devices of microprocessor, thereby {5}------------------------------------------------ controlling the volume of output laser energy and work pulse width, through the feedback loop, export the current sampling signal and send to the micro - processor for real-time monitoring. Various power supply components from the power system of laser hair removal instrument mostly adopt the safe and reliable switching power supply to achieve AC-DC conversion, these components passed through CE- certification, so that the safe effectiveness of the system get adequately guarantee, not only ensure the personal safety of users, but also ensures the long-term and reliable work of the devices itself. The power system has the perfect self-protection function, it can continuously feed a number of important signal back to the microprocessor, once the important signal has an error, the microprocessor will promptly notify the users through the friendly man-appliance interface (Touch Screen) and take automatic protection treatment .After the error sigmal is released, the power system can automatically return to normal state. #### b. Microprocessor Control System Diode Laser device adopt the microprocessor control system. The microprocessor control system is composed of microprocessor, control loop and detection circuit, see Fig 9-1. Control module of hair removal instrument is highly automated, the user just needs to turn on rocker switch and key switch and eject emergency stop switch, after power-on, the system will automatically perform the self-check for the control system (include all the preset checks against some possible damages to the appliance and the calling of treatment parameters and other a series of actions. #### c. Operation Display System Operation Display System is composed of touch screen, indicator and buzzer. Among them, the touch screen connect directly to the host microprocessor, the operator can operate the touch screen to control the microprocessor to work, and through the information that is displayed on the screen to understand the main unit state and the relevant parameters, the hair removal instrument adopt the safe and reliable touch screen that passed through CE certification, also, the manufacturer designed a simple and intuitive operational interface, which can be easy to realize man-machine dialogue. The indicators are used to display the work state of main unit; meanwhile, the buzzer is used as the prompt for laser output and fault alarm. #### d. Cooling System Cooling system consists of cooling fan, cooling water re-circulation system and water temperature regulation system. After the laser hair removal instrument starting, the cooling system begins to work and adjust the water temperature to the preset temperature scale. The cooling fan give air cooling for the electric {6}------------------------------------------------ parts and radiator in the main unit, through air flow in the appliance to take away the generated heat. When the laser is running, internal circulating water can displace and takes away the heat and deliver to the water temperature regulation system, where the heat can be displaced and sent to the radiator for dispersion. Therefore, the circulation water temperature is maintained within a dynamic balance range, this ensures the normal working temperature of laser. By monitoring cooling water temperature in real time through temperature sampling, the control system can start the cooling components from the water temperature regulation system in due time to adjust water temperature, also, it can automatically judges whether the temperature is normal. If the temperature exceeds the early warning value that preset, the system will automatically disable laser output and give alarm so as to avoid damage to the laser. #### e. Handpiece module Handpiece module is the heart of the device, which is the execution unit of the device and completes the laser emission function. The semiconductor laser emits light to output energy. {7}------------------------------------------------ - 6. Identification of Predicate Device and Reference Device Primary Predicate Device 510(k) Number: K181019 Product Name: Diode Laser System Manufacturer: Guangzhou Huafei Tongda Technology Co., Ltd. Reference Device 510(k) Number: K162659 Product Name: Diode Laser Hair Removal System Manufacturer: Shandong Huamei Technology Co.,ltd. - 7. Non-Clinical Test Conclusion Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: - > AAMI/ANIS/ES 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance; - > IEC 60601-2-22 Edition 3.1 2012-10, Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment. - > IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements. - > IEC 60601-1-2:2014 , Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests - > ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility) - > ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility) - 8. Clinical Test Conclusion No clinical study is included in this submission. {8}------------------------------------------------ # 9. Substantially Equivalent (SE) Comparison | Item | Proposed Device | Predicate Device | Reference Device | Remark | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Product Code | GEX | K181019 | K162659 | SE | | Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | SE | | Intended Use | The Diode Laser Therapy System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. | The Diode Laser System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. | The Diode Laser Hair Removal System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. | SE | | Configuration | Main Unit<br>Handpiece<br>Foot Control | Main Unit<br>Handpiece<br>Foot Control | Main Unit<br>Handpiece<br>Foot Control | SE | | Principle of Operation | Diode Laser | Diode Laser | Diode Laser | SE | # Table 7-1 General Comparison {9}------------------------------------------------ | Item | Proposed Device | Predicate Device<br>K181019 | Reference Device<br>K162659 | Remark | |----------------------|-----------------------|-----------------------------|-----------------------------|------------| | Laser Type | Diode Laser | Diode Laser | Diode Laser | SAME | | Laser Classification | Class IV | Class IV | Class IV | SAME | | Laser Wavelength | 808 nm | 808 nm | 808 nm | SAME | | Spot Size | $2.80\text{cm}^2$ | $1.20\text{cm}^2$ | $1.44 \text{ cm}^2$ | Discussion | | Pulse Duration | 3ms-400ms | 30ms-200ms | 5-400ms | Discussion | | Fluence | 2-40 J/ $\text{cm}^2$ | 5-40 J/ $\text{cm}^2$ | 1-120J/ $\text{ cm}^2$ | SAME | | Frequency | 1-10Hz | 1-5Hz | 0.5-15Hz | Discussion | | Power Supply | 110V~50/60Hz | 100-240V~ 50/60Hz | AC 110V/60Hz | Discussion | | Dimension | 510mm×600mm× | 510mm×600mm× | 450mm× | Discussion | | | 1000mm | 1000mm | 550mm×380mm | | | Weight | 45Kg | 50Kg | 52Kg | Discussion | Table 7-2 Performance Comparison #### Discussion The proposed device has same indication for use with predicate devices, the main differences are output parameters, such as spot size, frequency range, pulse duration. For these output parameters, the Fluence and Pulse duration are most important parameters which may decides that how much and how long time the energy will deliver to the patient's skin, it may effects the safety (too much energy and/or too long action time) may burn patient's skin, and effectiveness (too low energy and/or too short action time) may make the device could not achieve it's indication for use. From the comparison above, the fluence of proposed device is 5-40 J/cm2, the fluence of predicate device are 5-40 J/cm2. They are exactly same, that's means the proposed device has capable to achieve it's indication for use. The Pulse duration of proposed device is 3 ms -400 ms, which is difference with the predicate device, but which is same with the reference device (K162659), since the reference device has more longer fluence (120 J/cm2), then the 400 ms maximum pulse with 40 J/cm2 of proposed device could be consider as safety. For the other differences (Spot Size, Frequency, Power Supply, Dimension and Weight), they would not affects the safety and effectiveness of proposed device for it's indications for use. And By complying with non-clinical test conducted, the proposed device is determined to be substantially equivalency with predicate device. {10}------------------------------------------------ | Item | Proposed Device | Predicate Device<br>K162659 | Reference Device<br>K162659 | Remark | |------------------------------------------------|-----------------------------------------|-----------------------------------------|-----------------------------------------|--------| | Patient Contact Materials and Biocompatibility | | | | | | Patient Contact<br>Materials | Handpiece tip | Handpiece tip | Handpiece tip | SAME | | Cytotoxicity | No Cytotoxicity | No Cytotoxicity | No Cytotoxicity | | | Sensitization | No evidence of sensitization | No evidence of sensitization | No evidence of sensitization | SAME | | Irritation | No evidence of irritation | No evidence of irritation | No evidence of irritation | | | EMC, Electrical and Laser Safety | | | | | | Electrical<br>Safety | Comply with IEC 60601-1, IEC 60601-2-22 | Comply with IEC 60601-1, IEC 60601-2-22 | Comply with IEC 60601-1, IEC 60601-2-22 | SAME | | EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SAME | | Laser Safety | Comply with IEC 60601-2-22, IEC 60825 | Comply with IEC 60601-2-22, IEC 60825 | Comply with IEC 60601-2-22, IEC 60825 | SAME | ### Table 7-3 Safety Comparison ### 10. Substantially Equivalent (SE) Conclusion Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.