IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)

K251707 · Shenzhen Huachuangtong Industrial Co., Ltd. · OHT · Aug 1, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K251707
• Device Name: IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)
• Applicant: Shenzhen Huachuangtong Industrial Co., Ltd.
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Aug 1, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.

Device Story

Personal, light-based hair reduction device for OTC use. Input: user-initiated finger switch activation. Operation: Xenon lamp generates Intense Pulsed Light (IPL) to reduce hair growth without cutting or pulling. Safety feature: built-in skin sensor prevents light pulse emission unless full skin contact is detected. Output: light pulses applied to skin surface. Used by end-user at home. Healthcare provider does not interact with device output; device intended for self-administered hair reduction to benefit patient by reducing hair growth with minimal pain.

Clinical Evidence

Bench testing only. No clinical data presented. Biocompatibility testing performed per ISO 10993-5, ISO 10993-10, and ISO 10993-23. Electrical safety and EMC testing performed per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-83. Photobiological safety verified per IEC 62471.

Technological Characteristics

IPL hair removal system using Xenon arc lamp. Wavelength: 530-1200nm. Energy density: 2.08-4.58J/cm². Pulse duration: 6.0-8.0ms. Spot size: 2.4cm². Materials: ABS+PC, Aluminum alloy, Sapphire (model dependent). Power: External adapter (100-240V). Microprocessor-controlled with skin contact sensor. Compliance: ISO 10993, IEC 60601-1, IEC 60601-2-83, IEC 62471.

Indications for Use

Indicated for removal of unwanted body hair 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

• Intense Pulse Light Therapeutic Apparatus (K242595)

Reference Devices

• IPL Hair Removal Device (K250194)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

August 1, 2025

Shenzhen Huachuangtong Industrial Co., Ltd.
% Jenny Wu
Primary Correspondent
Shenzhen Huachuangtong Industrial Co., Ltd
Building 1, 3rd floor, Zhuolinxing Industrial Park, Liaokeng
3rd Industrial Zn, Baoyuan Community, Shiyan St, Bao'an Dist
Shenzhen, Guangdong 518106
China

Re: K251707
Trade/Device Name: IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)
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: May 18, 2025
Received: June 3, 2025

Dear Jenny Wu:

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.

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

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K251707 - Jenny Wu
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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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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 systems (QS) regulation (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-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

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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: 2025.08.01
00:09:18 -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) K251707 | |
| Device Name IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L) | |
| Indications for Use (Describe) IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair. | |
| 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 Huachuangtong Industrial Co., Ltd
510(k)s_510(k) Summary #K251707

# 510(k) Summary #K251707

This summary of 510(k) information is submitted as required by requirements of SMDA and 21 CFR §807.92.

## 1 Administrative Information

| Submission Date | May. 15, 2025
Submitter's Name: Shenzhen Huachuangtong Industrial Co., Ltd.
Address: Building 1, 3rd floor, Zhuolinxing Industrial Park, Liaokeng 3rd Industrial Zone, Baoyuan Community, Shiyan Street, Bao'an District, Shenzhen City, Guangdong Province, China. 518108
Contact person: Qixin Huang
TEL: [phone]
E-Mail: [e-mail] |
| --- | --- |
| Manufacturer information | |
| Submission Correspondent | Contact person: Ms Jenny.Wu
E-Mail: [e-mail]
Company: Shenzhen Huachuangtong Industrial Co., Ltd.
Address: Building 1, 3rd floor, Zhuolinxing Industrial Park, Liaokeng 3rd Industrial Zone, Baoyuan Community, Shiyan Street, Bao'an District, Shenzhen City, Guangdong Province, China. 518108
Tel: [phone] |

## 2 Device Information

| Common name of the device | IPL Hair Removal Device |
| --- | --- |
| Trade name of the device | IPL Hair Removal Device |
| Type/Model of the device | HCT-1208/HCT-1208B/HCT-1208L |
| Classification information | Classification panel: General & Plastic Surgery
Classification name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulation Number: 21 CFR 878.4810
Device Class: II
Product Code: OHT |
| type of 510(k) submission | Traditional |

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Shenzhen Huachuangtong Industrial Co., Ltd
510(k)s_510(k) Summary #K251707

# 3 Primary predicate Device Information and Reference predicate Device Information

| Predicate Device: Intense Pulse Light Therapeutic Apparatus | |
| --- | --- |
| Sponsor: | Shenzhen Greatro Electronic Technology Co., Ltd.
Intense Pulse Light Therapeutic Apparatus, |
| Device: | Model(s):
IPL-18 BF, IPL-18 FG |
| 510(K) Number: | K242595 |
| Product code: | OHT |
| Approval date: | November 6, 2024 |
| Reference Device: IPL Hair Removal Device | |
| --- | --- |
| Sponsor: | Shenzhen Ulike Smart Electronics Co., Ltd |
| Device: | IPL Hair Removal Device,
Model(s): UI06S PR, UI06S PN, UI06S WH |
| 510(K) Number: | K250194 |
| Product code: | OHT |
| Approval date: | March 26, 2025 |

# 4 Device Descriptions

The IPL Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The IPL Hair Removal Device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. There are HCT-1208/HCT-1208B/HCT-1208L 3 models in this application. Their work principle, intended use, structure, appearance, size, and operation are the same, with differences being product function are slight differences, but these parameters are within the predicate device and do not affect or change the intended use of the device.

# 5 Intended Use/ Indications for Use

IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.

# 6 SE Comparisons

The subject device IPL 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 do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device for its intended use. Therefore, the subject device may be found substantially equivalent to its predicate device. The subject device is compared with the

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Shenzhen Huachuangtong Industrial Co., Ltd

510(k)s_510(k) Summary #K251707

following Predicate Devices in terms of intended use, design, specifications, and performance:

Table 1. Substantial Equivalence Comparison

| Characteristics | Subject Device | Predicate device | Reference Device | Remark |
| --- | --- | --- | --- | --- |
| 510(k) Number | Pending | K242595 | K250194 | |
| Device Name | IPL Hair Removal Device | Intense Pulse Light Therapeutic Apparatus | Ice Cooling IPL Hair Removal Device | NA |
| Device Model | HCT-1208/HCT-1208B/HCT-1208L | IPL-18 BF, IPL-18 FG | UI06S PR, UI06S PN, UI06S WH | NA |
| Manufacturer | Shenzhen Huachuangtong Industrial Co., Ltd. | Shenzhen Greatro Electronic Technology Co., Ltd | Shenzhen Ulike Smart Electronics Co., Ltd. | NA |
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | |
| Product code | OHT | OHT | OHT | NA |
| Classification | Class II | II | Class II | NA |
| Intended Use/Indication for Use | IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair. | Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body hair. | 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, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. | SE |
| 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 | 100-240V, 50/60Hz | Input: AC100~240V50/60Hz Output: DC12V 3A | 100~240V, 50/60Hz | Same |
| Dimension | 179.6*60.2*34.25mm | IPL-18 BF: 154*79*46mm; IPL-18 FG: 154*79*46mm | 179.0*58.2*37.2mm | Different Note 01 |
| Weight | 290g | IPL-18 BF: 213g IPL-18 FG: 201g | / | |
| Treatment area | Large areas (e.g. arms, legs, chest) and small areas (e.g. lip) | Large areas (e.g. arms, legs, chest) and small areas (e.g. lip) | Large areas (e.g. arms, legs, chest) and small areas (e.g. lip) | Same |
| Light source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Same |

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Shenzhen Huachuangtong Industrial Co., Ltd

510(k)s_510(k) Summary #K251707

| Power source | Supplied by external adapter | Supplied by external adapter | Supplied by external adapter | Same |
| --- | --- | --- | --- | --- |
| Energy medium | Xenon Arc lamp | Xenon Arc lamp | Xenon Arc lamp | Same |
| Wavelength range | 530~1200nm | 510~1200nm | 550-1200mm | Different Note 02 |
| Energy density | 2.08-4.58J/cm² (Error: ±20%) | IPL-18 BF: 1.28~4.80J/cm²; IPL-18 FG: 1.52~5.89J/cm² | 2.42-7.27J/cm² | Different Note 03 |
| Output energy | 5.0-11.0J (Error: +/-20%) | Level 1: 6.0±1.2J Level 2: 7.5±1.5J Level 3: 9.5±1.9J Level 4: 11.0±2.2J Level 5: 13.0±2.6J Error is ±20% | 8-24J | |
| Spot size | 2.4cm² | IPL-18 BF: (3.5±0.25) cm²; IPL-18 FG: (2.9±0.25) cm² | 3.3cm² | |
| Pulse duration | 6.0ms-8.0ms (±20%) | 10.0±3.0ms | 1.82-8.07 ms | Different Note 04 |
| Pulsing control | Finger switch | Finger switch | Finger switch | Same |
| Output energy level | 1 to 5 level | 1 to 5 level | 1 to 4 level | Same |
| Software/Firmware/Microprocess or Control? | Yes | Yes | Yes | Same |
| Photobiological statement | Comply with IEC62471 requirements. | Comply with IEC62471 requirements. | Comply with IEC62471 requirements. | Same |
| Delivery device | Direct illumination to tissue | Direct illumination to tissue | Direct illumination to tissue | Same |
| Availability of skin sensors (that used to identify the presence or absence of skin areas) | Presence | Presence | Presence | Same |
| Skin-contacting components | Device enclosure and treatment panel | Device enclosure and treatment panel | Enclosure and treatment window | SE |
| Materials of skin-contacting components | HCT-1208L: ABS+PC; Aluminum alloy; Sapphire; HCT-1208B: ABS+PC; Aluminum alloy; HCT-1208: ABS+PC; | IPL-18 BF: PC+ABS plastic, POM, Glass, and Aluminum alloy; IPL-18 FG: PC+ABS plastic, POM, Glass | Unknown | Different Note 05 |
| Materials statement | All user directly contacting materials are compliance with ISO10993-5, ISO10993-10 and ISO 10993-23 requirements. | All user directly contacting materials are compliance with ISO10993-5, ISO10993-10 and ISO 10993-23 requirements. | All user directly contacting materials are compliance with ISO10993-5, ISO10993-10 and ISO 10993-23 requirements. | Same |
| EMC safety statement | Comply with IEC60601-1-2 requirements | Comply with IEC60601-1-2 requirements | Comply with IEC60601-1-2 requirements | Same |

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Shenzhen Huachuangtong Industrial Co., Ltd
510(k)s_510(k) Summary #K251707

| Electrical safety statement | Comply with IEC60601-1, IEC60601-1-11, IEC60601-2-83 requirements | Comply with IEC60601-1, IEC60601-1-11, IEC60601-2-83 requirements | Comply with IEC60601-1, IEC60601-1-11, IEC 60601-2-57 and IEC60601-2-83 requirements | Same |
| --- | --- | --- | --- | --- |
| Environment for operation | Temperature:5~30°C
Humidity:15%~75%RH | Temperature: 5°C~30°C
Humidity: ≤80%RH | / | Different Note 06 |
| Environment for storage | Temperature: -20~55°C
Humidity:15%~93%RH | Temperature: -10°C~60°C
Humidity: 5%~90% | / | |

Note01: The "Weight", "Dimension", is belonging to basic physical characteristics, although it is a little different from the predicate devices, it will not affect the main function and the intended use of the device. They all also comply with IEC60601-1 requirements. Besides, the subtle change of the physical characteristics will not affect the critical functions or normal use, and not raise any safety or effectiveness issues.

Note02: The "Wavelength range" of the subject device is little different from the predicate device. But the subject device complies with IEC60601-1 and IEC60601-2-83; so this difference will not raise any safety or effectiveness issues.

Note 03: The max "Energy density" and "Output energy" of the subject device is lower than the Reference device, so the subject device is substantially equivalent to the device. Although there is a minor difference in the spot size between the subject device and the predicate device, the spot size and output energy level which is related to energy density. The subject device complies with IEC60601-1 and IEC60601-2-83 and since the difference in energy density is not significant and be substantially equivalent, so this difference will not raise any safety or effectiveness issue.

Note04: The "Pulse duration" of the subject device is little different from the predicate device. But the subject device complies with IEC60601-1 and IEC60601-2-83; so this difference will not raise any safety or effectiveness issues.

Note05: Although the "skin contact components" and the "Materials of skin-contacting components" of the subject device and predicate device are not exactly the same, the skin-contacting components of the subject device has been tested and satisfied the standard requirements of ISO 10993-1. So this difference will not raise any safety/effectiveness problems.

Note06: Although the Environment for operation and storage of the subject device and predicate device are not exactly the same, the subject device has been tested and satisfied the standard requirements of IEC 60601-1. So this difference will not raise any safety/effectiveness problems.

These different technological characteristics of the subject devices do not raise different questions of safety and effectiveness. Thus, the subject device is Substantially Equivalent (SE) to the predicate devices which is legally marketed in US.

## 7 Performance Data

The following performance data were provided in support of the substantial equivalence determination.

### 1) Biocompatibility Testing

The biocompatibility evaluation for the body-contacting components of the IPL Hair Removal Device was conducted in accordance with the "Use of International Standard ISO 10993-1,

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Shenzhen Huachuangtong Industrial Co., Ltd
510(k)s_510(k) Summary #K251707

"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. The following testing was performed and passed, including:

- ISO 10993-5:2009, Biological evaluation of medical devices –Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2021, Biological evaluation of medical devices –Part 10: Tests for skin sensitization
- ISO 10993-23:2021, Biological evaluation of medical devices –Part 23: Tests for skin irritation

2) Electrical Safety and EMC

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

- IEC 60601-1, Edition 3.2 2020-08, Medical electrical equipment –Part 1: General requirements for basic safety and essential performance
- 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 disturbances - Requirements and tests.
- IEC 60601-1-11, Edition 2.1 2020-07, Medical Electrical Equipment –Part 1: 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, 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 Photobiological safety of lamps and lamp systems

4) Software Verification and Validation

Software documentation consistent with moderate 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.

## Summary

Based on the above performance as documented in this application, the subject device was found to have a safety and effectiveness profile that is similar to the predicate device.

## 8 Conclusions

The subject device:

IPL Hair Removal Device is respectively substantially equivalent to the predicate device (Intense Pulse Light Therapeutic Apparatus) manufactured by Shenzhen Greatro Electronic

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Shenzhen Huachuangtong Industrial Co., Ltd
510(k)s_510(k) Summary #K251707

Technology Co. (K242595) and reference device (IPL Hair Removal Device) manufactured by Shenzhen Ulike Smart Electronics Co., Ltd (K250194).

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