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.

AI/ML Overview

This document is an FDA 510(k) clearance letter for an IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L). The request asks to describe the acceptance criteria and the study that proves the device meets those criteria, specifically concerning performance beyond basic safety and electrical testing.

However, the provided 510(k) clearance letter and summary primarily focus on establishing substantial equivalence to predicate devices through comparisons of technical specifications and robust safety testing (biocompatibility, electrical safety, eye safety, and software verification).

There is no detailed information provided in this document regarding a clinical performance study (e.g., patient trials, or studies that measure the actual effectiveness of hair removal) beyond the statement that "Performance data supports that the device is safe and as effective as the predicate device for its intended use." The "Performance Data" section specifically lists only safety and software V&V, not clinical efficacy.

Therefore, I cannot fully complete all sections of your request as the provided text does not contain the specific clinical performance study details you are asking for. The clearance is based on the device being "substantially equivalent" to predicate devices that are already cleared for the specified indications for use, and a demonstration that the new device meets relevant safety standards and its software functions as intended.

Here's what can be extracted and inferred based on the provided document:

Acceptance Criteria and Device Performance (Based on Provided Document)

While the document doesn't detail specific clinical efficacy acceptance criteria for the hair removal function, it does outline acceptance criteria for safety and technical performance, which are crucial for FDA clearance. The "study" proving these are met refers to the various engineering and safety tests performed.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred/Stated)	Reported Device Performance / Study Results
Safety - Biocompatibility	Compliance with ISO 10993 standards for skin-contacting components (cytotoxicity, skin sensitization, skin irritation).	Passed: ISO 10993-5 (In vitro cytotoxicity), ISO 10993-10 (Skin sensitization), ISO 10993-23 (Skin irritation).
Safety - Electrical & EMC	Compliance with IEC 60601-1 series standards for general safety, electromagnetic disturbances, home healthcare, and light therapy equipment.	Passed: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83.
Safety - Eye Safety	Compliance with IEC 62471 for photobiological safety.	Passed: IEC 62471.
Software Functionality	Software requirement specifications met, hazards mitigated to acceptable risk levels. Consistent with moderate level of concern.	Passed: System validation testing demonstrated all software requirements met and hazards mitigated.
Substantial Equivalence	Device features, intended use, mode of action, and operational characteristics are similar to legally marketed predicate devices, and any differences do not raise new questions of safety or efficacy.	Determined: Subject device is substantially equivalent to predicate and reference devices in intended use, mode of action, and operational characteristics. Minor differences (size, weight, specific wavelengths, energy density, pulse duration, materials, environmental conditions) were assessed and deemed not to affect safety or effectiveness, with compliance to relevant IEC standards cited.

2. Sample Size Used for the Test Set and Data Provenance

Clinical Performance Test Set: Not applicable / Not specified in this document for a clinical efficacy study. The document focuses on bench testing and safety compliance.
Safety Testing (Biocompatibility, Electrical, Eye): The "sample size" for these tests would typically refer to the number of devices or material samples tested. This information is not detailed in the provided 510(k) summary (e.g., how many units underwent electrical safety testing).
Data Provenance: Implied to be from the manufacturer's own testing conducted in China (where the manufacturer is located). The nature of these tests (e.g., bench testing) makes the "retrospective or prospective" classification less applicable than for clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this type of submission. This 510(k) relies on standardized engineering and safety tests, and establishing "ground truth" for these types of tests is typically based on adherence to the specified international standards (e.g., IEC, ISO) and laboratory procedures, rather than expert consensus on observational data.

4. Adjudication Method for the Test Set

Not applicable for this type of submission. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where expert readers or evaluators independently assess data (e.g., medical images). The tests described here are compliance tests against predefined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is a specific type of clinical study used primarily for medical imaging devices to evaluate human reader performance with and without an AI algorithm. This document describes a physical hair removal device, not an imaging device, and does not mention any clinical comparative effectiveness study, especially not one involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable for this type of device. This device is a direct-use consumer product. While it has "Software Verification and Validation," this refers to the embedded software controlling the device's functions (e.g., light emission, skin sensor), not a standalone diagnostic algorithm whose performance would be measured independently.

7. The Type of Ground Truth Used

For safety and electrical performance: Ground truth is established by the requirements and methodologies outlined in the referenced international standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety). The device's performance is measured against the specifications and limits defined by these standards.
For substantial equivalence: The ground truth is the performance and safety data of the legally marketed predicate devices, against which the subject device is compared. The argument is that the subject device's technical characteristics and tested safety performance are "substantially equivalent" to these predicates.

8. The Sample Size for the Training Set

Not applicable. This document describes the clearance of a physical medical device, not a machine learning or AI model that requires a "training set" of data. The software verification mentioned refers to traditional software testing methodologies.

9. How the Ground Truth for the Training Set Was Established

Not applicable. (See point 8).

Summary

FDA 510(k) Clearance Letter - IPL Hair Removal Device

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.0 8 . 0 0
Silver Spring, MD 20993
www.fda.gov

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

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K251707 - Jenny Wu Page 2

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 (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)
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
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."

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Shenzhen Huachuangtong Industrial Co., Ltd
510(k)s_510(k) Summary #K251707
Page 1 of 7

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
Manufacturer information	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. 518108Contact person: Qixin HuangTEL: +86-18503025184E-Mail: 670945537@qq.com
Submission Correspondent	Contact person: Ms Jenny.WuE-Mail: jenny.wu@aivikon.comCompany: 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. 518108Tel: +8613316972203

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 SurgeryClassification name: Laser surgical instrument for use in general and plastic surgery and in dermatologyRegulation Number: 21 CFR 878.4810Device Class: IIProduct Code: OHT
type of 510(k) submission	Traditional

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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.
Device: Intense Pulse Light Therapeutic Apparatus, 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

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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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	179.660.234.25mm	IPL-18 BF: 1547946mm; IPL-18 FG: 1547946mm	179.058.237.2mm	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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Page 3 of 7

Characteristics	Subject Device	Predicate device	Reference Device	Remark
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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Characteristics	Subject Device	Predicate device	Reference Device	Remark
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℃ Humidity:15%~75%RH	Temperature: 5℃~30℃ Humidity: ≤80%RH	/	Different Note 06
Environment for storage	Temperature: -20~55℃ Humidity:15%~93%RH	Temperature: -10℃~60℃ 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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'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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Technology Co. (K242595) and reference device (IPL Hair Removal Device) manufactured by Shenzhen Ulike Smart Electronics Co., Ltd (K250194).

Regulation Number and Section

§ 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.