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.

Device Description

IPL Hair Removal Device is the fast professional IPL with 6 levels for DH4, 8 levels for DH5, DH5 Plus and DH5 Max, and offers a beauty removal.

IPL Hair Removal Devices of models: DH4, DH5 Plus and DH5 Max consist of IPL host and power adapter. The host is mainly composed of hair removal lamp, power/level button, skin sensor, thermovent (fan), flash button and DC socket.

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 IPL Hair Removal Devices of models DH5 Max have the cooling function, which will be activated throughout the whole process to cool down the treatment area's temperature and provide the user with a better using experience.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max), based on the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance related to hair removal efficacy. Instead, it focuses on the device's adherence to safety and performance standards for its operating characteristics. The criteria for equivalence are primarily based on the comparison of technological characteristics with predicate devices.

Acceptance Criteria (Implied/Derived from Comparison)	Reported Device Performance (from "Technological Comparison" and "Non-Clinical Tests Summary")
Functional Equivalence:
Intended Use	Same as predicate (unwanted hair removal, permanent reduction in hair regrowth at 6, 9, and 12 months)
Mode of Action	Same as predicate (Intense Pulsed Light)
Source Energy and Power Supply	Same as predicate (external adapter with 100-240V~, 50/60Hz)
Light Source	Same as predicate (Intense Pulsed Light)
Energy Medium	Same as predicate (Xenon Arc Flashlamp)
Wavelength	Same as predicate (510-1200nm)
Safety and Performance Characteristics:
Spot Size	DH4: 3.0cm²; DH5, DH5 Plus, DH5 Max: 3.0cm². This is different from the primary predicate (K173813) but the energy density is within the predicate's range, so deemed not to raise safety/effectiveness issues.
Energy Density	DH4: 2.0-4.0 J/cm²; DH5, DH5 Max: 2.3-4.5 J/cm². This is within the range of the primary predicate (1.8-5.1 J/cm²).
Pulse Duration	6.6-9.6ms. This is different from the primary predicate but within the minimum value range of both predicate devices, so deemed not to raise safety/effectiveness issues.
Output Energy Density Verification	Verified (Specific values or pass/fail not provided, assumed to meet internal specs and predicate comparison).
Pulse Duration Time Verification	Verified (Specific values or pass/fail not provided, assumed to meet internal specs and predicate comparison).
Valid Times of Flashes Verification	Verified (Specific values or pass/fail not provided, assumed to meet internal specs).
Biocompatibility (Cytotoxicity)	Compliant with ISO 10993-5: 2009.
Biocompatibility (Skin Sensitization)	Compliant with ISO 10993-10: 2021.
Biocompatibility (Irritation)	Compliant with ISO 10993-23: 2021.
Electrical Safety	Compliant with IEC 60601-1:2005/AMD1:2012/AMD2:2020.
Electromagnetic Compatibility	Compliant with IEC 60601-1-2:2014+A1:2020.
Home Healthcare Environment Compliance	Compliant with IEC 60601-1-11:2015/AMD1:2020.
Home Light Therapy Equipment Safety	Compliant with IEC 60601-2-83:2019.
Photobiological Safety	Compliant with IEC 62471:2006.

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

The document explicitly states: "Clinical test is not applicable, thus, there's no clinical data for the device." This indicates that there was no test set with human subjects for evaluating efficacy or clinical performance. The evaluation was based on non-clinical (engineering and lab) tests and comparison to predicate devices. Therefore, sample size and data provenance for a "test set" in a clinical context are not relevant to this submission.

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

As there was no clinical test set, there were no experts used to establish ground truth in a clinical sense. The "ground truth" for the non-clinical tests would be established by the engineering and quality control standards defined by the listed ISO and IEC standards.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is an IPL hair removal device, not an AI-assisted diagnostic or interpretation tool for human readers. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not directly applicable to an IPL hair removal device. The device's "standalone performance" is implicitly covered by the non-clinical tests verifying its physical and electrical characteristics according to established standards. It's a direct-use medical device, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is defined by the international and national standards listed (e.g., ISO 10993 series, IEC 60601 series, IEC 62471). These standards set the benchmarks and methodologies for evaluating biocompatibility, electrical safety, electromagnetic compatibility, and photobiological safety. For the comparison to predicate devices, the "ground truth" is the technical specifications and cleared indications for use of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. The device is not an AI/ML algorithm that requires a training set in the conventional sense. Its design and manufacturing processes might involve internal testing and validation, but not a "training set" like for predictive models.

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

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

October 17, 2024

Shenzhen Huaruibo Electric Appliances Co., Ltd % Tracy Che Registration Specialist Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Oianhai Road Shenzhen, Guangdong 518052 China

Re: K242197

Trade/Device Name: IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) 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: July 26, 2024 Received: July 26, 2024

Dear Tracy Che:

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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 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-reportingcombination-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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatory

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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,

Digitally signed by Yan Fu -S
Yan Fu -S Date: 2024.10.17 17:27:59
-04'00'

for

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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Indications for Use

510(k) Number (if known) K242197

Device Name

IPL Hair Removal Device (DH4. DH5. DH5 Plus, DH5 Max)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) #: K242197		Prepared on: 2024-10-09
Contact Details21 CFR 807.92(a)(1)
Applicant Name	Shenzhen Huaruibo Electric Appliances Co., Ltd
Applicant Address	3rd Floor, Building A, Chajiaokan Industrial Zone, Sanhe Village, HuarongCommunity, Dalang Street, Longhua District Shenzhen Guangdong518103 China
Applicant Contact Telephone	+86-13600412127
Applicant Contact	Mr. Xinhua Luo
Applicant Contact Email	kobe@data-hero.cn
Correspondent Name	Feiying Drug & Medical Consulting Technical Service Group
Correspondent Address	Rm 2401 Zhenye International Business Center, No. 3101-90,Qianhai Road Shenzhen Guangdong 518052 China
Correspondent Contact Telephone	+86-18027206248
Correspondent Contact	Ms. Tracy Che
Correspondent Contact Email	1273487536@qq.com
Device Name21 CFR 807.92(a)(2)
Device Trade Name	IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)
Common Name	Laser surgical instrument for use in general and plastic surgery and indermatology
Classification Name	Light Based Over-The-Counter Hair Removal
Regulation Number	878.4810
Product Code(s)	OHT
Legally Marketed Predicate Devices21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K173813	IPL Hair Removal Device Joy Version	OHT
K232932	Intense Pulse Light Therapeutic Apparatus	OHT
Device Description Summary21 CFR 807.92(a)(4)
IPL Hair Removal Device is the fast professional IPL with 6 levels for DH4, 8 levels for DH5, DH5 Plus and DH5 Max, and offers a beauty

y . 1 removal.

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Intended Use/Indications for Use

Indications for Use Comparison

The subject device and predicate devices have the same indications for use.

Technological Comparison

The technical characteristic of IPL Hair Removal Device (DH5 Max) are substantially equivalent to the predicate devices in the following aspects:

the same intended use, mode of action:
the same source energy and power supply: supplied by external adapter with 100-240V~, 50/60Hz;
the same light source: Intense Pulsed Light;
the same energy medium: Xenon Arc Flashlamp;
the same wavelength: 510-1200nm.

The difference between the subject device and the predicate devices mainly includes the following:

different spot size: the spot size DH4 is 3.0cm² for DH5, DH5 Plus, DH5 Max, which is different from the primary predicate device K173813. The spot size is related to energy density of the subject device is within the range of the predicate devices, so this difference will not raise any safety or effectiveness issue.
different energy density: the energy density of DH4 is 2.0-4.0/cm² and 2.3-4.5 J/cm² for DH5, DH5 Max while that of the primary predicate device is 1.8~5.1 J/cm². The energy density of subject device is within the range of the minimum and maximum value of the primary predicate.
different pulse duration: the device is 6.6-9.6ms, which is different from the primary predicate device, however it's within the range of the minimum value of both predicate devices, so this difference will not raise any safety or effectiveness issue.

Thus the subject device is determined to be substantially equivalent to the predicate devices.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

In order to verify and assure the performance, function and quality of the IPL Hair Removal Device, we have conducted the verification of output energy density, pulse duration time, valid times of flashes.

ISO 10993-5: 2009, Biological evaluation of medical devices –Par t 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 irritation

IEC 60601-1:2005/AMD1:2012/AMD2:2020 Medical electrical equirements for basic safety and essential performance

IEC 60601-1-2:2014+A1:2020 Medical electrical equipments for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests

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 Medical electrical equipments for the basic safety and essential performance of home light therapy equipment

IEC 62471:2006 Photobiological safety of lamps and lamp systems

Clinical test is not applicable, thus, there's no clinical data for the device.

The subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

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.