(90 days)
No.
The device description and performance studies do not mention any AI, ML, or DNN components, nor do they describe functionality that typically requires AI (e.g., image processing for diagnosis or complex adaptive control). The device's operations, like skin contact detection and cooling functions, are standard sensor-based or engineering controls.
Yes
The device is indicated for hair removal and permanent reduction in hair regrowth, which are therapeutic effects on the body.
No
The device description clearly states its purpose as a "Hair Removal Device" for "unwanted hair reduction" and "permanent reduction in hair regrowth" using Intense Pulsed Light (IPL). There is no mention of it being used to diagnose conditions or diseases.
No
The device is described as a "Hand-held Hair Removal Device" that uses "Intense Pulsed Light (IPL)" and has physical components like a "light exit," "skin sensor," and "cooling function." It also mentions "Electrical Safety and EMC testing" and "Biocompatibility Evaluation" for body-contacting components, all of which pertain to hardware, not software. Although "Software Verification and Validation" is included, it is only one component of a larger physical device.
No.
The device is an Intense Pulsed Light (IPL) hair removal device for personal use, which acts directly on the body for hair reduction. It does not perform in vitro examination of specimens derived from the human body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OHT
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 3.0cm² (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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper lip, chin, underarms, legs, arms, bikini area, chest, back, abdomen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home-use device
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination.
-
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. -
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.
- 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.
- Eye Safety
- IEC 62471, First edition 2006-07, Photobiological safety of lamps and lamp systems
-
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. -
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
510(k) Summary #K251000
Page 1
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:
Page 2
| 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 3.0cm² (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 3
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 4
| 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, legs, 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 5
| Comparison Elements | Subject Device | Predicate Device | Reference device 1 | Reference device 2 | Remark |
|---|---|---|---|---|---|
| Dimension | FZ-200A: 1996858(mm) FZ-201: 1796439mm FZ-202: 20213293mm CT05, CT06: 17964039(mm) CT07: 20417354(mm) CT08: 19214054(mm) CT09: 17712091(mm) | FZ-608, FZ-608G: 9814760(mm) FZ-100: 1987144(mm) FZ-200: 2166852(mm) | 12678200mm | 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 | 510-1200mm | 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 6
| Comparison Elements | Subject Device | Predicate Device | Reference device 1 | Reference device 2 | Remark |
|---|---|---|---|---|---|
| Software/ Firmware/ Microprocessor Control? | Yes | FZ-200: 6 levels 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 7
- 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 8
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)
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