The IPL Hair Removal Device is a hand-held device that utilizes Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device includes three models with the only difference in enclosure color. It is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission a skin sensor to detect appropriate skin contact, if the flash window is not in full contact with the skin, the device cannot emit the treatment light pulses. The device has a cooling function for a better hair remove experience.

AI/ML Overview

This document is a 510(k) summary for an IPL Hair Removal Device (BE932C, BE932D, BE932E). It's a submission to the FDA seeking to demonstrate substantial equivalence to legally marketed predicate devices.

The document states that clinical testing was NOT applicable, and there is NO clinical data. This means there is no study described that proves the device meets specific acceptance criteria based on human performance or improvement. Instead, the focus is on demonstrating substantial equivalence through technological comparison and non-clinical testing.

Therefore, many of the requested details about acceptance criteria and study proving device performance are not present in this document, as they relate to clinical studies that were not performed.

However, I can extract information related to the non-clinical testing performed to demonstrate substantial equivalence.

Here's a breakdown of what is available and what is not:

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

Acceptance Criteria (Implicit from non-clinical testing standards): The device is required to meet various international and FDA-recognized standards for safety, electrical compatibility, and biocompatibility.
- IEC 60601-1: 2020 (Medical electrical equipment - General requirements for basic safety and essential performance)
- IEC 60601-1-2: 2020 (Electromagnetic disturbances)
- IEC 60601-1-11: 2020 (Home healthcare environment)
- IEC 60601-2-83: 2022 (Home light therapy equipment)
- IEC 62471: 2006 (Photobiological safety)
- ISO 10993-5: 2009 (Biocompatibility - In Vitro Cytotoxicity)
- ISO 10993-10: 2021 (Biocompatibility - Skin Sensitization)
- ISO 10993-23: 2021 (Biocompatibility - Irritation)
- FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices" (Software verification and validation)
- "Applying Human Factors and Usability Engineering to Medical Devices" (Product usability)
Reported Device Performance: The document states that "The testing results demonstrate that the subject device complies with the following standards" and lists the standards above.
- Technological similarities to predicates are also presented as a form of performance equivalence (e.g., wavelength, output energy, pulse duration within range of predicates).

2. Sample size used for the test set and the data provenance

This document is for a non-clinical submission. There is no "test set" in the sense of a clinical trial. The testing refers to engineering tests performed on the device itself.
Data provenance: Not specified, but generally, these tests are conducted by the manufacturer or accredited testing labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable as there is no clinical test set or human "ground truth" establishment in this filing. The "ground truth" for non-clinical testing is adherence to the specified engineering and safety standards.

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

Not applicable. There's no human reader component that would require an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "The clinical test is not applicable, there is no clinical data."

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

Not applicable in the context of an AI algorithm as this is an IPL device, not an AI diagnostic tool. Software verification and validation were performed for the device's inherent software.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is compliance with established international and FDA-recognized engineering, electrical, photobiological safety, and biocompatibility standards. The device is being compared to its predicate devices for technological equivalence rather than against a clinical ground truth like pathology or patient outcomes.

8. The sample size for the training set

Not applicable. There is no AI model or training set described.

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

Not applicable.

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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration" in a larger font. The word "Administration" is written in a smaller font below the other words.

September 23, 2024

Shenzhen Yang Wo Electronic Co., Ltd % Riley Chen Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen, Guangdong 518052 China

Re: K241834

Trade/Device Name: IPL Hair Removal Device (BE932C, BE932D, BE932E) 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: June 24, 2024 Received: June 25, 2024

Dear Riley Chen:

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

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

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 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 Re"). 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.

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).

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

Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/deviceadvice-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.

Digitally signed by TANISHA TANISHA L. HITHE -S L. HTHE - ○ Date: 2024.09.23
22:25:54 -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

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

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241834

Device Name

IPL Hair Removal Device (BE932C, BE932D, BE932E)

Indications for Use (Describe)

The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial 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."

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

510(k) Summary
Contact Details		21 CFR 807.92(a)(1)
Applicant Name		Shenzhen Yang Wo Electronic Co., Ltd
Applicant Address		101# 3Bldg, The third industry, Shangshi jia Village, Shijia Community,Matian Street, GuangMing District Shenzhen Guangdong 518106 China
Applicant Contact Telephone		+86-13058187625
Applicant Contact		Mr. Ken Wang
Applicant Contact Email		wangkun@beautigo.com
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 13660660449
Correspondent Contact		Ms. Riley Chen
Correspondent Contact Email		c3714930@gmail.com
Device Name		21 CFR 807.92(a)(2)
Device Trade Name		IPL Hair Removal Device (BE932C, BE932D, BE932E)
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 Devices		21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K220645	Hand-held IPL device (JOVS Hair Removal Device)	OHT
K230122	IPL Hair Removal Device	OHT
K192432	IPL Home Use Hair Removal Device	OHT
Device Description Summary		21 CFR 807.92(a)(4)

technology. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.

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

The device includes three models with the only difference in enclosure color. It is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission a skin sensor to detect appropriate skin contact, if the flash window is not in full contact with the skin, the device cannot emit the treatment light pulses. The device has a cooling function for a better hair remove experience.

Intended Use/Indications for Use

The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.

Indications for Use Comparison

The subject device and the primary predicate device have indications for use, they are both over-the-counter devices intended for removal of unwanted body and/ or facial hair.

Technological Comparison

The technological characteristics of the subject devices (K220645 and K230122) and reference device (K192432) are substantially equivalent in the following aspects:

Design: hand-held
Energy source: power by external power adapter, input 100-240V, 50/60Hz
Energy medium: Xenon Arc Flashlamp
Light source: Intense Pulsed Light (IPL)
The following main output parameters are similar with the predicates and the reference device:

a) the wavelength (600~~1200nm) of the subject device is within the range of the primary predicate device, K220645 (590~~1200mm); b) the output energy is within the range of the primary predicate device (K220645) and the energy density is in the range of the secondary predicate device (K230122);

c) the pulse duration is within the range of the reference device (K192432)

The main difference between the subject device and reference devices is product dimensions, but this difference is insignificant and do not raise any safety or effectiveness problems.

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)

Non-clinical testings have been conducted to verify that the PL Hair Removal Device meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate devices. The testing results demonstrate that the subject device complies with the following standards:

IEC 60601-1: 2020, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: 2020, Medical electrical equirements for basic safety and essential performance -Collateral standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-11: 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: 2022, 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

The device has been tested for biocompatibility, it complies with the following standards.

ISO 10993-5: 2009, Biological Evaluation of Medical Devices - Part 5: Tests for InVitro 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

We have also conducted:

Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"

The product usability has been evaluated according to "Applying Human Factors and Usability Engineering to Medical Devices"

The clinical test is not applicable, there is no clinical data.

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

{6}------------------------------------------------

The subject device is as safe, as effective, and performs as well as the 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.