IVYLASER Handhold Hair Removal Machine

{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 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. July 3, 2023 Ivylaser (Beijing) Technology Co., Ltd. % Eva Li Consultant Microkn Medical Technology Service (Shanghai) Co.,Ltd. Room 901, No. 889, Pinglu Road, Jing'an District Shanghai (Shanghai Jing'an HUAFA Center) Shanghai, 200435 China Re: K230025 Trade/Device Name: IVYLASER Handhold Hair Removal Machine 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: OHT Dated: January 4, 2023 Received: January 4, 2023 Dear Eva Li: 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. Jianting Wang -S Jianting Wang 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) K230025 Device Name IVYLASER Handhold Hair Removal Machine #### Indications for Use (Describe) IVYLASER Handhold Hair Removal Machine is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. IVYLASER is also intended for permanent har reduction 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> Prescription Use (Part 21 CFR 801 Subpart D) | | <span></span> 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 K230025 ## 1. Contact information ### 1.1. Applicant Applicant Name: Ivylaser (Beijing) Technology Co., Ltd. Address: Room 411, Building 3, No. 2 Shengfang Road, Daxing District, Beijing Contact Person: Yuan Xiujuan Title: General Manager Assistant Tel: 086-01060299801 Email: yuanxiujuan@oriental-laser.com #### 1.2. Consultant Company: Microkn Medical Technology Service (Shanghai) Co., Ltd. Address: Room 901, No. 889, Pinglu Road, Jing'an District, Shanghai (Shanghai Jing'an HUAFA Center) Contact Person: Heather. Wang Telephone: +86 13166194697 Email: heather.wang@microkn.com {4}------------------------------------------------ ## 2. Device information - Trade Name: IVYLASER Handhold Hair Removal Machine ● - Model(s): iyoung mini-P, iyoung mini-GY, iyoung mini-GN ● - Classification: II ● - Product Code: OHT ● - Regulation Number: 21 CFR. 878.4810 . #### 3. Intended use/Indications for Use IVYLASER Handhold Hair Removal Machine is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. IVYLASER is also intended for permanent hair reduction 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. ## 4. Legally Marketed Predicate Device Product name: SILKPRO Laser Hair Removal System 510(k) Number: K142845 Product Code: OHT Manufacture: Wuhan Lotuxs Technology Co., Ltd. {5}------------------------------------------------ # 5. Description of the device The proposed device is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. It is also intended for permanent hair reduction Three models (iyoung mini-P, iyoung mini-GY, iyoung mini-GN) are included in IVYLASER Handhold Hair Removal Machine series products, and they have the same intended purposes and working theories. {6}------------------------------------------------ The main components list of proposed device shown in Table 1. | Description | Quantity | Function Description | |------------------|----------|--------------------------------------| | Device host | 1 | For removing hair from the body. | | Power<br>adapter | 1 | Provides stable current and voltage. | Table 1 Main Components list of Proposed Device ### 6. 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: - . IEC 60601-1 Medical electrical device Part1: General requirements for basic safety and essential performance - IEC 60601-1-2 Medical electrical equipment- Part 1-2: General . requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests - IEC 60825-1 Safety of laser products -Part 1: Equipment classification ● and requirements - ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests ● for In Vitro cytotoxicity - . ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity {7}------------------------------------------------ ## 7.Clinical Test Conclusion No clinical study is included in this submission. # 8.Predicate Devices Product name: SILKPRO Laser Hair Removal System 510(k) Number: K142845 Product Code: OHT Manufacture: Wuhan Lotuxs Technology Co., Ltd. ## 9.Substantially Equivalent (SE) Comparison The IVYLASER Handhold Hair Removal Machine has been carefully compared to legally marketed devices with respect to intended use, configuration, performance comparison (Table 2), physical specifications comparison (Table 3) and safety comparison (Table 4). | Item | Proposed Device | Predicate Device | Remark | |-------------------------|----------------------------------------|----------------------------------------|--------| | Product<br>Code | OHT | OHT | SE | | 510K<br>Number | K230025 | K142845 | / | | Classificati<br>on Name | Laser Instrument,<br>Surgical, Powered | Laser Instrument,<br>Surgical, Powered | SE | | Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | SE | Table 1 General Comparison {8}------------------------------------------------ | Number | | | | |-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| | Panel | General & Plastic<br>Surgery | General & Plastic<br>Surgery | SE | | Class | Class II | Class II | SE | | Intended<br>Use | IVYLASER Handhold<br>Hair Removal Machine<br>is an over-the-counter<br>device intended for<br>adjunctive use with<br>shaving for hair<br>removal sustained with<br>periodic treatments.<br>IVYLASER is also<br>intended for permanent<br>hair reduction defined<br>as the long-term, stable<br>reduction in the number<br>of hairs regrowing<br>when measured at 6, 9,<br>and 12 months after the<br>completion of a<br>treatment regime. | SILKPRO laser hair<br>removal system adopts<br>the 810nm diode laser,<br>which targets on<br>the hair follicle and<br>slows the process of hair<br>growth. It is used to<br>remove unwanted hair<br>of body. SILKPRO is<br>also intended for<br>permanent hair<br>reduction defined as the<br>long-term, stable<br>reduction in the number<br>of hairs regrowing when<br>measured at 6, 9, and 12<br>months after the<br>completion of a<br>treatment regime. | SE, with<br>difference in<br>wording,<br>while the<br>actual<br>intended<br>use are<br>the same. | | | IVYLASER Handhold | | | | | Hair Removal Machine | SILKPRO is an | | | | is an over-the-counter | over-the-counter device | | | | device intended for | intended for adjunctive | | | | adjunctive use with | use with shaving for hair | | | | shaving for hair | removal sustained with | | | | removal sustained with | periodic treatments. | | | | periodic treatments. | SILKPRO is also | | | Indications | IVYLASER is also | intended for permanent | | | for Use | intended for permanent | hair reduction defined as | SE | | | hair reduction defined | the long-term, stable | | | | as the long-term, stable | reduction in the number | | | | reduction in the number | of hairs regrowing when | | | | of hairs regrowing | measured at 6, 9, and 12 | | | | when measured at 6, 9, | months after the | | | | and 12 months after the | completion of a | | | | completion of a | treatment regime. | | | | treatment regime. | | | {9}------------------------------------------------ # Table 2 Performance Comparison | Item | Proposed Device | Predicate Device | Remark | |------------|-----------------|------------------|--------------| | Laser Type | Diode Laser | Diode Laser | SE | | Wavelength | 808nm | 810nm | Discussion 1 | {10}------------------------------------------------ | Max Energy<br>Density (Per Sec) | 15.43 J/cm² | 25J/cm² | Discussion 2 | |---------------------------------|------------------------------------------------------------------|--------------------------------------------------|--------------| | Energy Density<br>(Per Sec) | 1.85 J/cm², 3.09 J/cm²,<br>6.17J/cm², 9.26 J/cm²,<br>15.43 J/cm² | 5J/cm², 10J/cm²,<br>15J/cm²,<br>20J/cm², 25J/cm² | Discussion 2 | | Laser Beam | 9mm×18mm | 9mm×9mm | Discussion 2 | | Pulse Width | Maximum: 600ms<br>Minimum: 50ms | Maximum: 408.1ms<br>Minimum: 68.06ms | Discussion 3 | | Frequency | Maximum: 5hz<br>Minimum: 0.5hz | Maximum: 1hz<br>Minimum: 0.24hz | Discussion 3 | Table 3 Physical Specifications Comparison | Item | Proposed Device | Predicate Device | Remark | |--------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-----------------| | Operating<br>Environment | Temperature: 5~28°C;<br>Humidity: <70% | Temperature:<br>+5°C~+40°C;<br>Humidity: ≤80% | Discussion<br>4 | | Storage<br>Environment | Temperature: 10°C~30°C;<br>Humidity: 30%~75%;<br>Atmospheric pressure:<br>860hPa~1060hPa | Temperature:<br>-40°C~+55°C;<br>Humidity: ≤ 90%;<br>Atmospheric<br>pressure: 700~1060hPa | Discussion<br>4 | | Input Voltage | 100~240V, 50/60Hz | 100~240V, | SE | {11}------------------------------------------------ | | | 50/60Hz | | |-----------|------------------|------------------|----| | Usability | Button operation | Button operation | SE | #### Discussion 1 The Proposed Device uses a wavelength of 808nm. The device is safe for human body according to IEC 60825-1 test report, report details please refer to VOL 017. #### Discussion 2 There are some differences on the energy density and laser beam between proposed device and predicate device. The laser beam of the proposed device is larger than that of the predicate device. However, the energy density is lower of the proposed device, and both of the devices comply with IEC 60825-1. Therefore, the safety and effectiveness won't be affected and they can be considered substantially equivalent in safety and effectiveness. #### Discussion 3 The proposed device is different in pulse width and frequency from the predicate device. But the energy density of the proposed device is lower than the predicate device and both of the devices comply with IEC 60825-1. Therefore, the safety and effectiveness won't be affected and they can be considered substantially equivalent in safety and effectiveness. #### Discussion 4 9 {12}------------------------------------------------ There are some differences on the operating and storage environment between proposed device and predicate device. But the proposed device has passed the transportation test according to ASTM D4169-2016 and shelf life verification test, details please refer to VOL_014. Therefore, the safety and effectiveness won't be affected and they can be considered substantially equivalent in safety and effectiveness. {13}------------------------------------------------ Safety comparison has been done to validate the biocompatibility specification, EMC and safety of the device (Table 4). | Item | Proposed Device | Predicate Device | Remark | |----------------------------------|---------------------------------|---------------------------------|--------| | Biocompatibility | | | | | Cytotoxicity | No Cytotoxicity | No Cytotoxicity | SE | | Skin<br>sensitization | No evidence of<br>sensitization | No evidence of<br>sensitization | SE | | Irritation | No evidence of<br>irritation | No evidence of<br>irritation | SE | | EMC, Electrical and Laser Safety | | | | | Electrical<br>safety | Comply with IEC<br>60601-1 | Comply with IEC<br>60601-1 | SE | | EMC | Comply with IEC<br>60601-1-2 | Comply with IEC<br>60601-1-2 | SE | | Laser safety | Comply with IEC<br>60825-1 | Comply with IEC<br>60825-1 | SE | Table 4 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.