Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)

{0} Shenzhen Chuangtong Yigou Technology Co., Ltd 510(k)s –510(k) Summary K251000 # 510(k) Summary #K251000 "510(k) Summary" as required by 21 CFR Part 807.92. ## I. Submitter Shenzhen Chuangtong Yigou Technology Co., Ltd Room 2218, Rongchuang Zhihui Building A, Shangfen Community, Minzhi Street, Longhua District, Shenzhen, China Kingway Hong Manager Tel: +86 13410362992 Email: kingway.hong@ctonetech.com ## II. Preparation date: 6/30/2025 ## III. Device Name of Device: Hand-held Hair Removal Device Model(s): FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09. Common or Usual Name: Light Based Over-The-Counter Hair Removal Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: OHT Regulation Number: 21 CFR 878.4810 ## IV. Predicate Device and Reference Devices Predicate device: {1} Shenzhen Chuangtong Yigou Technology Co., Ltd 510(k)s -510(k) Summary K251000 | Manufacturer | Predicate Device | 510(k) Number | Approval Date | | --- | --- | --- | --- | | Shenzhen IONKA Medical Technology Co., Ltd. | Hand-held IPL device (IPL Home Use Hair Removal Device), (Model: FZ-608, FZ-608G, FZ-100, FZ-200) | K230739 | May 26, 2023 | **Reference devices:** | Manufacturer | Reference Devices | 510(k) Number | Approval Date | | --- | --- | --- | --- | | Shen Zhen CosBeauty Co., Ltd | IPL Hair Removal Device Joy Version, CB-027 | K173813 | Sept. 07, 2018 | | Shenzhen Ulike Smart Electronics Co.,Ltd | IPL Hair Removal Device Model(s): UI06 PL, UI06 PN, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD | K223618 | Feb 28, 2023 | ## V. Device Description Hand-held Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed eight models with the same IPL technology for hair removal, which is model FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09. The device works below the skin’s surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The Hand-held Hair Removal Device has an irreplaceable light exit and it can cover an area of $3.0\mathrm{cm}^2$ (Model BFZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) that is suitable for multiple hair removal areas, such as upper lip, chin, underarms, legs, arms, bikini area, chest, back, abdomen. Page 2/9 {2} Shenzhen Chuangtong Yigou Technology Co., Ltd 510(k)s –510(k) Summary K251000 The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the Hand-held Hair Removal Device has the cooling function (suitable for model CT05, CT06, CT07, CT08, CT09), which can be activated throughout the whole hair removal process to cool down the treatment area’s temperature and provide the user with a better using experience. ## VI. Indications for Use Hand-held Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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. ## VII. Materials | Component name | Material of Component | Body Contact Category | Contact Duration | | --- | --- | --- | --- | | Hand-held Hair Removal Device | PC, ABS, POM | Surface-contacting device: Intact skin | Less than 24 hours | ## VIII. Comparison of Technological Characteristics With the Predicate Device The Hand-held Hair Removal Device has the same intended use, mode of action and similar operational characteristics as the predicate device. Any minor differences between the subject device and the listed predicate device and reference devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device and reference devices for its intended use. Therefore, the Hand-held Hair Removal Device may be found substantially equivalent to its predicate device and reference devices. Hand-held Hair Removal Device is compared with the following Predicate Device and Reference Devices in terms of intended use, design, material, specifications, and performance: Page 3/9 {3} Shenzhen Chuangtong Yigou Technology Co., Ltd 510(k)s -510(k) Summary K251000 | Comparison Elements | Subject Device | Predicate Device | Reference device 1 | Reference device 2 | Remark | | --- | --- | --- | --- | --- | --- | | 510(k) Number | K251000 | K230739 | K173813 | K223618 | / | | Trade name | Hand-held Hair Removal Device Model: FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09 | Hand-held IPL device (IPL Home Use Hair Removal Device) Model: FZ-608, FZ-608G, FZ-100, FZ-200 | IPL Hair Removal Device Joy Version, CB-027 | IPL Hair Removal Device | / | | Manufacturer | Shenzhen Chuangtong Yigou Technology Co., Ltd. | Shenzhen IONKA Medical Technology Co., Ltd. | Shen Zhen CosBeauty Co., Ltd | Shenzhen Ulike Smart Electronics Co.,Ltd. | / | | Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same | | Product code | OHT | OHT | OHT | OHT | Same | | Device classification | Class II | Class II | Class II | Class II | Same | | Indication for use/ Intended use | Hand-held Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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. | IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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 IPL Hair Removal Device Joy Version is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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 device is used for adults with Fitzpatrick skin types I - IV. | IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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. | Same | | Prescription or OTC | OTC | OTC | OTC | OTC | Same | | Applicable skin | Fitzpatrick skin types I-V | Fitzpatrick skin types I-V | Fitzpatrick skin types I-IV | Fitzpatrick skin types I-V | Same | | Treatment area | upper lip, chin, underarms, 1 egs, arms, bikini area, chest, back, abdomen | Unknown | Large areas (legs, arms, back and abdomen), face (upper lip, chin and sideburns) | Large areas (e.g. arms, legs, chest) and small areas (e.g. lip) | Same | Page 4/9 {4} Shenzhen Chuangtong Yigou Technology Co., Ltd 510(k)s -510(k) Summary K251000 | Dimension | FZ-200A: 199*68*58(mm) FZ-201: 179*64*39mm FZ-202: 202*132*93mm CT05, CT06: 179*640*39(mm) CT07: 204*173*54(mm) CT08: 192*140*54(mm) CT09: 177*120*91(mm) | FZ-608, 98*147*60(mm) FZ-100: 198*71*44(mm) FZ-200: 216*68*52(mm) | 126*78*200mm | 58×34×179mm (W x H x D) | Difference Note 1 | | --- | --- | --- | --- | --- | --- | | Power supply | 100-240V, 50/60Hz, 0.8AMax | Unknown | 100-240 VAC, 50/60Hz | 100-240 VAC, 50/60Hz | Same | | Sterilization | Not required | Not required | Not required | Not required | Same | | Light source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Same | | Energy medium | Xenon Arc lamp | Xenon Arc lamp | Xenon Arc Flash lamp | Xenon Arc Flash lamp | Same | | Wavelength range | 590-1200nm | 510-1200nm | 510-1200nm | 560-1200nm | Similar Note 2 | | Energy density | 2-4.3 J/cm² | FZ-608, FZ-608G: 3.33 J/cm² FZ-100: 5.43 J/cm² FZ-200: 4.5 J/cm² | 1.8~5.1J/cm² | 3~6 J/cm² | Similar Note 3 | | Output energy | 6-13 J | FZ-608, FZ-608G: Level 1: 4.16J Level 2: 4.36J Level 3: 5.1J Level 4: 6.1J Level 5: 6.96J Level 6: 7.96J Level 7: 8.63J Level 8: 9.13J Level 9: 10.0J | Body lamp cartridge: 11.77~22.21J, 510-1200nm Facial lamp cartridge: 3.65-7.04J, 512-1197nm Bikini lamp cartridge: 3.84-7.22J, 511-1200nm | 9.9~19.8J | Similar Note 3 | | Spot size | 3cm² | 3cm² | Body: 4.2cm² Bikini and face: 2.0cm² | 3.3cm2 | Similar Note 4 | | Pulse duration | 2-6 ms | 0.5-0.8ms | 9.2~11.2ms | 1ms~7ms | Similar Note 5 | | Pulsing control | Finger switch | Finger switch | Finger switch | Finger switch | Same | | Output intensity level | 9 levels | FZ-608, FZ-608G: 9 levels FZ-100: 9 levels | 5 | 3 | Same | Page 5/9 {5} Shenzhen Chuangtong Yigou Technology Co., Ltd 510(k)s –510(k) Summary K251000 | | | FZ-200: 6 levels | | | | | --- | --- | --- | --- | --- | --- | | Software/ Firmware/ Microprocessor Control? | Yes | Yes | Yes | Yes | Same | | Electrical safety | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-83 | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-83 | IEC 60601-1 IEC 60601-1-2 IEC 60601-2-57 | ANSI AAMI ES 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-83 | Same | | Eye safety | IEC 62471 | Unknown | Unknown | IEC 62471 | Same | | Biocompatibility | ISO 10993-5 ISO 10993-10 | ISO 10993-5 ISO 10993-10 | ISO 10993-5 ISO 10993-10 | ISO 10993-5 ISO 10993-10 | Same | ## IX. Performance Data The following performance data were provided in support of the substantial equivalence determination. ### 1) Biocompatibility Evaluation - The biocompatibility evaluation for the body-contacting components of the Hand-held Hair Removal Device was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on September 4, 2020", as recognized by FDA. ### 2) Electrical Safety and EMC Electrical safety and EMC testing was performed to, and passed, as per the following standards: - IEC 60601-1-2, Edition 4.1 2020-09, Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance –Collateral standard: electromagnetic compatibility. - IEC 60601-1, Edition 3.2 2020-08, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. - IEC 60601-1-11, Edition 2.1 2020-07, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. Page 6/9 {6} Shenzhen Chuangtong Yigou Technology Co., Ltd 510(k)s –510(k) Summary K251000 - IEC 60601-2-83, 2019+AMD1:2022, Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment. ## 3) Eye Safety - IEC 62471, First edition 2006-07, Photobiological safety of lamps and lamp systems ## 4) Software Verification and Validation Software documentation consistent with *basic documentation level* of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. ## 5) Usability The product usability has been evaluated and verified according to the following FDA guidance - Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016. ## X. Conclusions Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device Hand-held Hair Removal Device is as safe, as effective, and performs as well as the legally marketed predicate device. Page 7/9 {7} FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K251000 | | | Device Name Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) | | | Indications for Use (Describe) Hand-held Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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) ☐ 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." | | {8} Shenzhen Chuangtong Yigou Technology Co., Ltd 510(k)s –510(k) Summary K251000 # 510(k) Summary #K251000 "510(k) Summary" as required by 21 CFR Part 807.92. ## I. Submitter Shenzhen Chuangtong Yigou Technology Co., Ltd Room 2218, Rongchuang Zhihui Building A, Shangfen Community, Minzhi Street, Longhua District, Shenzhen, China Kingway Hong Manager Tel: +86 13410362992 Email: kingway.hong@ctonetech.com ## II. Preparation date: 6/30/2025 ## III. Device Name of Device: Hand-held Hair Removal Device Model(s): FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09. Common or Usual Name: Light Based Over-The-Counter Hair Removal Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: OHT Regulation Number: 21 CFR 878.4810 ## IV. Predicate Device and Reference Devices Predicate device: {9} Shenzhen Chuangtong Yigou Technology Co., Ltd 510(k)s -510(k) Summary K251000 | Manufacturer | Predicate Device | 510(k) Number | Approval Date | | --- | --- | --- | --- | | Shenzhen IONKA Medical Technology Co., Ltd. | Hand-held IPL device (IPL Home Use Hair Removal Device), (Model: FZ-608, FZ-608G, FZ-100, FZ-200) | K230739 | May 26, 2023 | **Reference devices:** | Manufacturer | Reference Devices | 510(k) Number | Approval Date | | --- | --- | --- | --- | | Shen Zhen CosBeauty Co., Ltd | IPL Hair Removal Device Joy Version, CB-027 | K173813 | Sept. 07, 2018 | | Shenzhen Ulike Smart Electronics Co.,Ltd | IPL Hair Removal Device Model(s): UI06 PL, UI06 PN, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD | K223618 | Feb 28, 2023 | ## V. Device Description Hand-held Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed eight models with the same IPL technology for hair removal, which is model FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09. The device works below the skin’s surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The Hand-held Hair Removal Device has an irreplaceable light exit and it can cover an area of $3.0\mathrm{cm}^2$ (Model BFZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) that is suitable for multiple hair removal areas, such as upper lip, chin, underarms, legs, arms, bikini area, chest, back, abdomen. Page 2/9 {10} Shenzhen Chuangtong Yigou Technology Co., Ltd 510(k)s –510(k) Summary K251000 The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the Hand-held Hair Removal Device has the cooling function (suitable for model CT05, CT06, CT07, CT08, CT09), which can be activated throughout the whole hair removal process to cool down the treatment area’s temperature and provide the user with a better using experience. ## VI. Indications for Use Hand-held Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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. ## VII. Materials | Component name | Material of Component | Body Contact Category | Contact Duration | | --- | --- | --- | --- | | Hand-held Hair Removal Device | PC, ABS, POM | Surface-contacting device: Intact skin | Less than 24 hours | ## VIII. Comparison of Technological Characteristics With the Predicate Device The Hand-held Hair Removal Device has the same intended use, mode of action and similar operational characteristics as the predicate device. Any minor differences between the subject device and the listed predicate device and reference devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device and reference devices for its intended use. Therefore, the Hand-held Hair Removal Device may be found substantially equivalent to its predicate device and reference devices. Hand-held Hair Removal Device is compared with the following Predicate Device and Reference Devices in terms of intended use, design, material, specifications, and performance: Page 3/9 {11} Shenzhen Chuangtong Yigou Technology Co., Ltd 510(k)s -510(k) Summary K251000 | Comparison Elements | Subject Device | Predicate Device | Reference device 1 | Reference device 2 | Remark | | --- | --- | --- | --- | --- | --- | | 510(k) Number | K251000 | K230739 | K173813 | K223618 | / | | Trade name | Hand-held Hair Removal Device Model: FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09 | Hand-held IPL device (IPL Home Use Hair Removal Device) Model: FZ-608, FZ-608G, FZ-100, FZ-200 | IPL Hair Removal Device Joy Version, CB-027 | IPL Hair Removal Device | / | | Manufacturer | Shenzhen Chuangtong Yigou Technology Co., Ltd. | Shenzhen IONKA Medical Technology Co., Ltd. | Shen Zhen CosBeauty Co., Ltd | Shenzhen Ulike Smart Electronics Co.,Ltd. | / | | Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same | | Product code | OHT | OHT | OHT | OHT | Same | | Device classification | Class II | Class II | Class II | Class II | Same | | Indication for use/ Intended use | Hand-held Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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. | IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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 IPL Hair Removal Device Joy Version is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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 device is used for adults with Fitzpatrick skin types I - IV. | IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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. | Same | | Prescription or OTC | OTC | OTC | OTC | OTC | Same | | Applicable skin | Fitzpatrick skin types I-V | Fitzpatrick skin types I-V | Fitzpatrick skin types I-IV | Fitzpatrick skin types I-V | Same | | Treatment area | upper lip, chin, underarms, 1 egs, arms, bikini area, chest, back, abdomen | Unknown | Large areas (legs, arms, back and abdomen), face (upper lip, chin and sideburns) | Large areas (e.g. arms, legs, chest) and small areas (e.g. lip) | Same | Page 4/9 {12} Shenzhen Chuangtong Yigou Technology Co., Ltd 510(k)s -510(k) Summary K251000 | Dimension | FZ-200A: 199*68*58(mm) FZ-201: 179*64*39mm FZ-202: 202*132*93mm CT05, CT06: 179*640*39(mm) CT07: 204*173*54(mm) CT08: 192*140*54(mm) CT09: 177*120*91(mm) | FZ-608, 98*147*60(mm) FZ-100: 198*71*44(mm) FZ-200: 216*68*52(mm) | 126*78*200mm | 58×34×179mm (W x H x D) | Difference Note 1 | | --- | --- | --- | --- | --- | --- | | Power supply | 100-240V, 50/60Hz, 0.8AMax | Unknown | 100-240 VAC, 50/60Hz | 100-240 VAC, 50/60Hz | Same | | Sterilization | Not required | Not required | Not required | Not required | Same | | Light source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Same | | Energy medium | Xenon Arc lamp | Xenon Arc lamp | Xenon Arc Flash lamp | Xenon Arc Flash lamp | Same | | Wavelength range | 590-1200nm | 510-1200nm | 510-1200nm | 560-1200nm | Similar Note 2 | | Energy density | 2-4.3 J/cm² | FZ-608, FZ-608G: 3.33 J/cm² FZ-100: 5.43 J/cm² FZ-200: 4.5 J/cm² | 1.8~5.1J/cm² | 3~6 J/cm² | Similar Note 3 | | Output energy | 6-13 J | FZ-608, FZ-608G: Level 1: 4.16J Level 2: 4.36J Level 3: 5.1J Level 4: 6.1J Level 5: 6.96J Level 6: 7.96J Level 7: 8.63J Level 8: 9.13J Level 9: 10.0J | Body lamp cartridge: 11.77~22.21J, 510-1200nm Facial lamp cartridge: 3.65-7.04J, 512-1197nm Bikini lamp cartridge: 3.84-7.22J, 511-1200nm | 9.9~19.8J | Similar Note 3 | | Spot size | 3cm² | 3cm² | Body: 4.2cm² Bikini and face: 2.0cm² | 3.3cm2 | Similar Note 4 | | Pulse duration | 2-6 ms | 0.5-0.8ms | 9.2~11.2ms | 1ms~7ms | Similar Note 5 | | Pulsing control | Finger switch | Finger switch | Finger switch | Finger switch | Same | | Output intensity level | 9 levels | FZ-608, FZ-608G: 9 levels FZ-100: 9 levels | 5 | 3 | Same | Page 5/9 {13} Shenzhen Chuangtong Yigou Technology Co., Ltd 510(k)s –510(k) Summary K251000 | | | FZ-200: 6 levels | | | | | --- | --- | --- | --- | --- | --- | | Software/ Firmware/ Microprocessor Control? | Yes | Yes | Yes | Yes | Same | | Electrical safety | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-83 | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-83 | IEC 60601-1 IEC 60601-1-2 IEC 60601-2-57 | ANSI AAMI ES 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-83 | Same | | Eye safety | IEC 62471 | Unknown | Unknown | IEC 62471 | Same | | Biocompatibility | ISO 10993-5 ISO 10993-10 | ISO 10993-5 ISO 10993-10 | ISO 10993-5 ISO 10993-10 | ISO 10993-5 ISO 10993-10 | Same | ## IX. Performance Data The following performance data were provided in support of the substantial equivalence determination. ### 1) Biocompatibility Evaluation - The biocompatibility evaluation for the body-contacting components of the Hand-held Hair Removal Device was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on September 4, 2020", as recognized by FDA. ### 2) Electrical Safety and EMC Electrical safety and EMC testing was performed to, and passed, as per the following standards: - IEC 60601-1-2, Edition 4.1 2020-09, Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance –Collateral standard: electromagnetic compatibility. - IEC 60601-1, Edition 3.2 2020-08, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. - IEC 60601-1-11, Edition 2.1 2020-07, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. Page 6/9 {14} Shenzhen Chuangtong Yigou Technology Co., Ltd 510(k)s –510(k) Summary K251000 - IEC 60601-2-83, 2019+AMD1:2022, Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment. ## 3) Eye Safety - IEC 62471, First edition 2006-07, Photobiological safety of lamps and lamp systems ## 4) Software Verification and Validation Software documentation consistent with *basic documentation level* of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. ## 5) Usability The product usability has been evaluated and verified according to the following FDA guidance - Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016. ## X. Conclusions Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device Hand-held Hair Removal Device is as safe, as effective, and performs as well as the legally marketed predicate device. Page 7/9