Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)

K254047 · Shenzhen Chuangtong Yigou Technology Co., Ltd. · OHT · Mar 11, 2026 · General, Plastic Surgery

Device Facts

• Record ID: K254047
• Device Name: Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)
• Applicant: Shenzhen Chuangtong Yigou Technology Co., Ltd.
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Mar 11, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Over-the-counter, home-use IPL hair removal device; eighteen models (CT/CTU/DT series). Device uses Xenon Arc lamp to emit light pulses (560-1200nm or 590-1200nm) to reduce hair growth via thermal effect below skin surface. User-operated via finger switch; requires external power adapter. Features skin contact sensor to prevent pulse emission unless fully contacted. Includes integrated cooling (standard or sapphire) to manage treatment area temperature. Output energy and spot size vary by model (3.0cm² or 4.2cm²). Healthcare provider does not operate; user self-administers. Output affects hair follicle growth cycle; benefits patient through long-term hair reduction.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence includes biocompatibility (ISO 10993), electrical safety/EMC (IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-83), photobiological eye safety (IEC 62471), and usability engineering per FDA guidance.

Technological Characteristics

IPL-based hair removal; Xenon Arc lamp source. Materials: AL-6063, PC+ABS (AC2300, PC2805), ABS 15E1, Corning/Quartz glass. Dimensions vary by model. Power: AC 100-240V. Cooling: Integrated or Sapphire. Connectivity: None. Sterilization: Not required. Software: Microprocessor-controlled, Basic Documentation Level.

Indications for Use

Indicated for removal of unwanted hair and permanent reduction in hair regrowth in individuals with Fitzpatrick Skin Types I-V.

Regulatory Classification

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.

Predicate Devices

• Hand-held Hair Removal Device (K251000)
• IPL Home Use Hair Removal Device (K252209)
• Ice Cooling IPL Hair Removal Device (K250942)

Reference Devices

• IPL Cooling Hair Removal Device (K232845)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

March 11, 2026

Shenzhen Chuangtong Yigou Technology Co., Ltd.
% Candice Qiu
Registration specialist
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center
# 3101-90, Qianhai Rd.
Shenzhen, Guangdong 518052
China

Re: K254047

Trade/Device Name: Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)

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: December 1, 2025

Received: December 17, 2025

Dear Candice Qiu:

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 (the 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 available 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.

U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

www.fda.gov

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K254047 - Candice Qiu
Page 2

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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-

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K254047 - Candice Qiu
Page 3

devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

TANISHA
L. HITHE-S
Digitally signed by
TANISHA L. HITHE-S
Date: 2026.03.11
23:34:00 -04'00'

Tanisha Hithe
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

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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services [phone]
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) K254047.IFU Final | |
| Device Name Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025) | |
| Indications for Use (Describe) 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 [e-mail] | |
| "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." | |

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Shenzhen Chuangtong Yigou Technology Co., Ltd
K254047 –510(k) Summary

# 510(k) Summary # K254047

"510(k) Summary" as required by 21 CFR Part 807.92.

## 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: [phone]
Email: [e-mail]
Preparation Date: February 6, 2026

## I. Device

Name of Device: Hair Removal Device
Model(s): CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017, DT017 Pro, DT025 Pro, DT025.
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

## II. Predicate Device and reference device

Page 1 of 12

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Shenzhen Chuangtong Yigou Technology Co., Ltd
K254047 –510(k) Summary

> For Model CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro

**Predicate device:**

| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
| --- | --- | --- | --- |
| Shenzhen Chuangtong Yigou Technology Co., Ltd. | Hand-held Hair Removal Device
(Model: FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) | K251000 | July 01, 2025 |

**reference device:**

| Manufacturer | reference device | 510(k) Number | Approval Date |
| --- | --- | --- | --- |
| Shenzhen Siken 3D Technology Development Co., Ltd. | IPL Cooling Hair Removal Device
(Model: SKB-1808) | K232845 | November 14, 2023 |

> For Model CTU05, CTU07, CTU09, CTU012, CTU015, CTU X

**Predicate device:**

| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
| --- | --- | --- | --- |
| Foshan Jindi Electric Appliance Co.,Ltd | IPL Home Use Hair Removal Device
(Model: JD-TM027) | K252209 | October 10, 2025 |

> For Model DT015 Pro, DT015, DT017, DT017 Pro, DT025, DT025 Pro

Page 2 of 12

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Shenzhen Chuangtong Yigou Technology Co., Ltd
K254047-510(k) Summary

**Predicate device:**

| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
| --- | --- | --- | --- |
| Shenzhen Ulike Smart Electronics Co.,Ltd. | Ice Cooling IPL Hair Removal Device
(Model: UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GK, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) | K250942 | July 11, 2025 |

**IV. Device Description**

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 eighteen models with the same IPL technology for hair removal, which is model CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017, DT017 Pro, DT025 Pro, DT025. 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 Hair Removal Device has an irreplaceable light exit and it can cover an area of $3.0\mathrm{cm}^2$ (Model CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X) and $4.2\mathrm{cm}^2$ (Model DT015 Pro, DT015, DT017, DT017 Pro, DT025, DT025 Pro) that is suitable for multiple hair removal areas, such as upper lip, chin, armpits, 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 Hair Removal Device has the Ice-cooling function (Model: CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12) and Sapphire Ice-cooling function (Model: CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017, DT017 Pro, DT025 Pro, DT025), which will 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.

**V. Indications for 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.

Page 3 of 12

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Shenzhen Chuangtong Yigou Technology Co., Ltd
K254047-510(k) Summary

VI. Materials

| Model | Component name | Material of Component | Body Contact Category | Contact Duration |
| --- | --- | --- | --- | --- |
| CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro | Host of device (including air outlet, treatment window, air inlet, buttons, filter) | AL-6063, PC+ABS AC2300, PC2805, Corning glass | Surface-contacting device: Intact skin | Less than 24 hours |
| CTU05, CTU07, CTU09, CTU012, CTU015, CTU X | | PC+ABS AC2300, PC2805, ABS 15E1, Aluminium oxide, Corning glass | | |
| DT015 Pro, DT015, DT017, DT017 Pro, DT025 Pro, DT025 | | PC+ ABS, PC, Aluminium oxide, Quartz glass | | |

VII. Comparison of Technological Characteristics With the Predicate Device

The 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 device 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 device for its intended use. Therefore, the Hair Removal Device may be found substantially equivalent to its predicate device and reference device.

Hair Removal Device is compared with the following Predicate Device and reference device in terms of intended use, design, material, specifications, and performance:

For CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro

| Comparison Elements | Subject Device | Predicate Device | Reference Device | Remark |
| --- | --- | --- | --- | --- |
| 510(k) Number | Pending | K251000 | K232845 | / |

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Shenzhen Chuangtong Yigou Technology Co., Ltd
K254047 –510(k) Summary

| Comparison Elements | Subject Device | Predicate Device | Reference Device | Remark |
| --- | --- | --- | --- | --- |
| 510(k) Number | Pending | K251000 | K232845 | / |
| Trade name | Hair Removal Device | Hand-held Hair Removal Device | IPL Cooling Hair Removal Device | / |
| Model | CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro | FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09 | SKB-1808 | / |
| Manufacturer | Shenzhen Chuangtong Yigou Technology Co., Ltd. | Shenzhen Chuangtong Yigou Technology Co., Ltd. | Shenzhen Siken 3D Technology Development Co., Ltd. | / |
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Product code | OHT | OHT | OHT | Same |
| Device classification | Class II | Class II | Class II | Same |
| Indication for use/ Intended 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. | 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 Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair. | Same |
| Prescription or OTC | OTC | OTC | OTC | Same |
| Applicable skin | Fitzpatrick Skin Types I-V | Fitzpatrick skin types I-V | Fitzpatrick Skin Types I-V | Same |
| Power supply | Input: AC 100-240V, 50/60 Hz, 0.8A
Output: 24VDC, 1.5A | 100-240V, 50/60Hz, 0.8AMax | Input: AC100~240V 50/60Hz
Output: DC12V 4A | Same |

Page 5 of 12

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Shenzhen Chuangtong Yigou Technology Co., Ltd
K254047 –510(k) Summary

| Comparison Elements | Subject Device | Predicate Device | Reference Device | Remark |
| --- | --- | --- | --- | --- |
| 510(k) Number | Pending | K251000 | K232845 | / |
| Dimension | 201(W)x71(H)x52(L)mm | 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) | 203*161*58mm | Difference Note 1 |
| Sterilization | Not required | Not required | Not required | Same |
| Light source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Same |
| Energy medium | Xenon Arc lamp | Xenon Arc lamp | Xenon Arc Flashlamp | Same |
| Wavelength range | 590nm-1200nm | 590-1200nm | 590-1200nm | Same |
| Energy density | 2-4.4J/cm² | 2-4.3 J/cm² | Max. 4.8J/cm² (range in 2.1~4.8J/cm²) | Similar Note 2 |
| Output energy | 6-13J(±20%) | 6-13 J | 8-12J | Same |
| Spot size | 3.0cm² | 3cm² | 3cm² | Same |
| Pulse duration | 8-15ms | 2-6 ms | 10±5ms | |
| Pulsing control | Finger switch | Finger switch | Finger switch | Same |
| Output intensity level | 9 levels | 9 levels | 5 levels | Same |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | Same |

Page 6 of 12

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Shenzhen Chuangtong Yigou Technology Co., Ltd
K254047 –510(k) Summary

| Comparison Elements | Subject Device | Predicate Device | Reference Device | Remark |
| --- | --- | --- | --- | --- |
| 510(k) Number | Pending | K251000 | K232845 | / |
| Electrical safety | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | Same |
| | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | |
| | IEC 60601-1-11 | IEC 60601-1-11 | IEC 60601-1-11 | |
| | IEC 60601-2-83 | IEC 60601-2-83 | IEC 60601-2-83 | |
| Eye safety | IEC 62471 | IEC 62471 | IEC 62471 | Same |
| Biocompatibility | ISO 10993-5 | ISO 10993-5 | ISO 10993-5 | Same |
| | ISO 10993-10 | ISO 10993-10 | ISO 10993-10 | |
| | ISO 10993-23 | | | |

> For CTU05, CTU07, CTU09, CTU012, CTU015, CTU X

| Comparison Elements | Subject Device | Predicate Device | Remark |
| --- | --- | --- | --- |
| 510(k) Number | Pending | K252209 | / |
| Trade name | Hair Removal Device | IPL Home Use Hair Removal Device | / |
| Model | CTU05, CTU07, CTU09, CTU012, CTU015, CTU X | JD-TM027 | / |
| Manufacturer | Shenzhen Chuangtong Yigou Technology Co., Ltd. | Foshan Jindi Electric Appliance Co.,Ltd | / |
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Product code | OHT | OHT | Same |
| Device classification | Class II | Class II | Same |
| Indication for use/ Intended 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 | IPL Home Use Hair Removal Device is an over-the counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, | Same |

Page 7 of 12

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Shenzhen Chuangtong Yigou Technology Co., Ltd
K254047 –510(k) Summary

| Comparison Elements | Subject Device | Predicate Device | Remark |
| --- | --- | --- | --- |
| 510(k) Number | Pending | K252209 | / |
| | the completion of a treatment regime. | 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. | |
| Prescription or OTC | OTC | OTC | Same |
| Applicable skin | Fitzpatrick Skin Types I-V | Fitzpatrick Skin Types I-V | Same |
| Power supply | 100-240V, 50/60 Hz | 100~240V, 50/60Hz | Same |
| Dimension | 115(W)x69(H)x41(L)mm | 182*60*35mm | Difference Note 1 |
| Sterilization | Not required | Not required | Same |
| Light source | Intense Pulsed Light | Intense Pulsed Light | Same |
| Energy medium | Xenon Arc lamp | Xenon Arc flashlamp | Same |
| Wavelength range | 560nm-1200nm | 550-1200nm | Similar Note 2 |
| Energy density | 2.6-4.7J/cm² | 2± 0.4~8± 1.6J/cm² | Similar Note 3 |
| Output energy | 8-14J(±20%) | 6± 1.2~24 ±4.8J | Similar Note 3 |
| Spot size | 3.0cm² | 3.0± 0.2cm² | Same |
| Pulse duration | 1.52-8.32ms | 0.2± 0.04ms~10ms± 2ms | Similar Note 4 |
| Pulsing control | Finger switch | Finger switch | Same |
| Output intensity level | 5 levels | 5levels~9levels | Same |
| Software/ Firmware/ Microprocessor Control? | Yes | Yes | Same |
| Electrical safety | IEC 60601-1 | IEC 60601-1 | Same |

Page 8 of 12

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Shenzhen Chuangtong Yigou Technology Co., Ltd
K254047-510(k) Summary

| Comparison Elements | Subject Device | Predicate Device | Remark |
| --- | --- | --- | --- |
| 510(k) Number | Pending | K252209 | / |
| | IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83 | IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-57 | |
| Eye safety | IEC 62471 | IEC 62471 | Same |
| Biocompatibility | ISO 10993-5
ISO 10993-10
ISO 10993-23 | ISO 10993-5
ISO 10993-10
ISO 10993-23 | Same |

> For DT015 Pro, DT015, DT017, DT017 Pro, DT025, DT025 Pro

| Comparison Elements | Subject Device | Predicate Device | Remark |
| --- | --- | --- | --- |
| 510(k) Number | Pending | K250942 | / |
| Trade name | Hair Removal Device | Ice Cooling IPL Hair Removal Device | / |
| Model | DT015 Pro, DT015, DT017, DT017 Pro, DT025, DT025 Pro | UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK | / |
| Manufacturer | Shenzhen Chuangtong Yigou Technology Co., Ltd. | Shenzhen Ulike Smart Electronics Co.,Ltd. | / |
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Product code | OHT | OHT | Same |
| Device classification | Class II | Class II | Same |
| Indication for use/ Intended 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 | Ice Cooling IPL Hair Removal Device with sapphire treatment window 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, | Same |

Page 9 of 12

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Shenzhen Chuangtong Yigou Technology Co., Ltd
K254047 –510(k) Summary

| Comparison Elements | Subject Device | Predicate Device | Remark |
| --- | --- | --- | --- |
| 510(k) Number | Pending | K250942 | / |
| | the completion of a treatment regime. | stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. | |
| Prescription or OTC | OTC | OTC | Same |
| Applicable skin | Fitzpatrick Skin Types I-V | Fitzpatrick Skin Types I-V | Same |
| Power supply | 100-240V, 50/60 Hz | 100-240V~, 50/60Hz | Same |
| Dimension | 198(W)x64(H)x40(L)mm | 206.73mm*68.68mm*54.29mm | Difference Note 1 |
| Sterilization | Not required | Not required | Same |
| Light source | Intense Pulsed Light | Intense Pulsed Light | Same |
| Energy medium | Xenon Arc lamp | Xenon Arc Flashlamp | Same |
| Wavelength range | 560nm-1200nm | 550-1200mm | Similar Note 2 |
| Energy density | 2.1-5J/cm² | 1.65~6.92J/cm² | Similar Note 3 |
| Output energy | 9.1-21J(±20%) | 4.29~27J | Similar Note 3 |
| Spot size | 4.2cm² | 3.9cm² | Similar Note 4 |
| Pulse duration | 0.86-5.96ms quadruple pulse | 0.86-6.32ms double pulse quadruple pulse | Similar Note 5 |
| Pulsing control | Finger switch | Finger switch | Same |

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Shenzhen Chuangtong Yigou Technology Co., Ltd
K254047 –510(k) Summary

| Comparison Elements | Subject Device | Predicate Device | Remark |
| --- | --- | --- | --- |
| 510(k) Number | Pending | K250942 | / |
| Output intensity level | 5 levels | 1-10 levels | Difference
Note 1 |
| Software/
Firmware/
Microprocessor Control? | 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 60601-2-57
IEC 60601-2-83 | Same |
| Eye safety | IEC 62471 | IEC 62471 | Same |
| Biocompatibility | ISO 10993-5
ISO 10993-10
ISO 10993-23 | ISO 10993-5
ISO 10993-10
ISO 10993-23 | Same |

## VIII. 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 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 recommended by FDA.

### 2) Electrical Safety and EMC

Electrical safety and EMC testing was performed to, and passed, as per the following standards:

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Shenzhen Chuangtong Yigou Technology Co., Ltd K254047-510(k) Summary

- 60601-1-2:2014+A1:2020: General requirements for basic safety and essential performance – Collateral standard: electromagnetic compatibility.
- IEC 60601-1:2005/AMD1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-11:2015/AMD1:2020 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.

## 3) Eye Safety

- IEC 62471:2006 (first Eition) Photobiological safety of lamps and lamp systems.

## 4) Software Verification and Validation

Software documentation consistent with Basic Documentation Level 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.

## IX. Conclusions

Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device Hair Removal Device is as safe, as effective, and performs as well as the legally marketed predicate device.

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