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 to perform hair removal. The device mainly consists of IPL main body and power adapter two parts and it is only powered by the external power adapter, as well as the flash window located in the main body which is the source of optical radiation, namely a Xenon flashlamp and its IPL emission activation is by finger switch. If the flash window of the device is not properly applied to the treatment area, the device cannot be triggered a pulse. There are six models in this application: S1-A, S2-A, S1, S2, S3, and S4. According to the declaration of the manufacturer, the difference of all models is mainly the exception of the product appearance, display contents on the display and the spot size of treatment window which does not affect the intended use. The spot size of model S1-A is designed to 3.0cm², model S1, S2, S3, and S4 is designed to 4.1cm², as well as the energy density of the all models is in the range of 2.2~5.6J/cm2.

AI/ML Overview

The provided text is a 510(k) Summary for an IPL Hair Removal Device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria for efficacy in hair removal.

Therefore, many of the requested details about acceptance criteria, device performance studies, sample sizes, expert involvement, and ground truth establishment cannot be found in this document.

The document primarily covers:

Device identification and classification.
Comparison to predicate devices based on technical specifications (wavelength, energy density, spot size, etc.) and intended use, asserting similarity.
Performance data related to safety standards: Biocompatibility, Electrical Safety, Eye Safety, and Software Verification and Validation. These are laboratory/engineering tests, not clinical efficacy studies for hair removal.

Here's an attempt to answer the questions based only on the provided text, indicating where information is absent:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for hair removal efficacy or provide reported device performance data in terms of hair reduction percentage or similar metrics. It focuses on demonstrating safety and technical similarity to a predicate device.

However, it does list several safety standards that the device "passed." If we interpret "acceptance criteria" as meeting these standards and "reported device performance" as passing them, then:

Acceptance Criteria (Testing Standard)	Reported Device Performance
ISO 10993-5 Biocompatibility	Passed
ISO 10993-10 Biocompatibility	Passed
IEC 60601-1-2 Electrical Safety	Passed
IEC 60601-1 Electrical Safety	Passed
IEC 60601-1-11 Electrical Safety	Passed
IEC 60601-2-57 Electrical Safety	Passed
IEC 62471 Photobiological Safety	Passed
Software Verification & Validation	Software requirement specifications met, hazards mitigated.

No performance metrics related to hair removal efficacy are provided.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to engineering and safety testing, not clinical trials on human subjects for efficacy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided. Ground truth in the context of hair removal efficacy usually refers to clinical assessment of hair count or density, often by experts. The document focuses on meeting general safety and electrical standards, not on clinical efficacy.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided. Adjudication methods are relevant for subjective assessments, typically in expert-based ground truth establishment for clinical trials, which is not described here.

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

An MRMC study is relevant for AI-assisted diagnostic devices. This document is for an IPL Hair Removal Device, which does not involve human "readers" interpreting images with AI assistance. Therefore, this question is not applicable to the content of this document.

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

This question is not applicable. The device is an IPL hair removal device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the safety and electrical standards testing, the "ground truth" is defined by the specific requirements and measurement methods outlined in each referenced ISO/IEC standard. For example, for biocompatibility, it's about whether the device materials cause a specific biological reaction (toxicity, irritation). For electrical safety, it's about whether it meets specified limits for leakage current, insulation, etc.

However, for hair removal efficacy, which is the device's intended function, no ground truth or study data is provided in this summary.

8. The sample size for the training set

This information is not provided. The device is not an AI/ML model that would have a "training set" in the context of deep learning.

9. How the ground truth for the training set was established

This information is not applicable as the device is not an AI/ML model with a training set.

Summary of what is present in the document:

The provided document is an FDA 510(k) summary, which is primarily focused on demonstrating "substantial equivalence" to a previously cleared predicate device. It strongly emphasizes meeting various safety and electrical standards through testing (biocompatibility, electrical safety, eye safety, software validation). It does not contain direct clinical performance data for hair removal efficacy, nor does it describe trials with human subjects for that purpose. The basis for clearance is the demonstrated safety and technical similarity to an already cleared device for the same indication.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 26, 2022

Shenzhen Yuwei Electronic Technology Co., Ltd. % Rain Yip Registered Engineer Feiying Drug & Medical Consulting Technical Service Group Rm2401, ZhenYe International Center, No.3101-90 Qianhai Road Nanshan District Shenzhen, Guangdong 518000 China

Re: K220222

Trade/Device Name: IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4 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: January 18, 2022 Received: January 26, 2022

Dear Rain Yip:

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 (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 located 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.

{1}------------------------------------------------

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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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-regulatoryassistance/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,

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K220222

Device Name

IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4

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)

X 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."

{3}------------------------------------------------

510(k) Summary

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

Date: 2022-01-18

I. Submitter

Shenzhen Yuwei Electronic Technology Co., Ltd. 409, Building 3, 1970 Science Park, Minzhi Community, Minzhi Street, Longhua District, Shenzhen, P.R.C 518000 Tel.: +86 186 7634 5905

Liu Xuemeng Quality Manager Tel: +86 186 7634 5905 Email: a369235@126.com

II. Device

Name of Device: IPL Hair Removal Device Model(s): S1-A, S2-A, S1, S2, S3, S4 Common or Usual Name: Light Based Over-The-Counter For Hair Removal Classification 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

III. Predicate Device

Predicate device: Home Use IPL Beauty Device/MS-208B, K210311, cleared by July 23, 2021

Reference device: IPL Home Use Hair Removal Device/D-1128, K192432, cleared by November 8. 2019

IV. Device Description

{4}------------------------------------------------

There are six models in this application: S1-A, S2-A, S1, S2, S3, and S4. According to the declaration of the manufacturer, the difference of all models is mainly the exception of the product appearance, display contents on the display and the spot size of treatment window which does not affect the intended use. The spot size of model S1-A is designed to 3.0cm², model S1, S2, S3, and S4 is designed to 4.1cm², as well as the energy density of the all models is in the range of 2.2~5.6J/cm2.

V. Indications for Use

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

VI. Comparison of Technological Characteristics With the Predicate Device

The IPL Hair Removal Device has the same intended use, mode of action and similar operational characteristics as the predicate devices. Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device for its intended use. Therefore, the IPL Hair Removal Device may be found substantially equivalent to its predicate device. IPL Hair Removal Device is compared with the following Predicate Device in terms of intended use, design, material, specifications, and performance:

Comparison Elements	Subject Device	Predicate Device K210311
K Number	Pending	K210311
Trade name	IPL Hair Removal Device	Home Use IPL Beauty DeviceModel: MS-208B
Wavelength range	610-1100nm	510-1100nm
Energy medium	Xenon Arc Flashlamp	Xenon Arc Flashlamp
Energy density	$2.2{\sim}5.6 J/cm^2$	$2.0{\sim}5.1J/cm^2$
Spot size	$3.0cm^2, 4.1cm^2$	$3.6cm^2$
Pulse duration	8~14ms	9-12ms
Pulsing control	Finger switch	Finger switch
Delivery device	Direct illumination tissue	Direct illumination tissue
Indicationforuse/Intended use	IPL Hair Removal Device is anover-the-counter device intendedfor removal of unwanted bodyhair.	The Home Use IPL BeautyDevice is an over-the-counterdevice intended for removal ofunwanted hair such as but notlimited to small areas such asunderarm and facial hair belowthe chin line and large areas suchas legs.
Location for use	OTC	OTC

{5}------------------------------------------------

VII.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 subject 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", as recognized by FDA. The battery of testing was performed to, and passed, including: > ISO 10993-5 Biological Evaluation of Medical Devices -Par t 5: Tests for In Vitro

Cytotoxicity
ISO 10993-10 Biological Evaluation of Medical Devices –Par t 10: Tests for Irritation and Skin Sensitization

2) Electrical Safety and Eye Safety

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

IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11 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 60601-2-57 Medical electrical equipment -- Part 2-57: Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
IEC 62471 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.

Summarv

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

VIII. Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, the subject device IPL Hair Removal Device is to be concluded substantial equivalent to its predicate devices.

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.