The IPL Home Use 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. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.

The IPL Home Use Hair Removal Device includes D-1150, D-1171, D-1153, D-1155, D-1156, D-1126, D-1178, D-1187 eight models. Their intended use, performance, structure design and operation are basically identical, with the differences contains product appearance, display contents and the number of button, lamp cartridge's quantity and appearance; in additional, due to the size of the treatment window in different lamp cartridge, the treatment area (spot size) and output density is a little different; but these differences do not affect or change the intended use of the device.

AI/ML Overview

This document is a 510(k) Summary for an IPL Home Use Hair Removal Device. It describes the device, compares it to predicate devices, and outlines the performance data submitted to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided document:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for a specific clinical outcome (e.g., a certain percentage of hair reduction). Instead, it relies on demonstrating substantial equivalence to predicate devices through various performance tests related to safety and general functionality.

However, we can infer the "acceptance criteria" for the tests performed as passing the relevant safety standards.

Acceptance Criteria (Inferred from tests performed)	Reported Device Performance
Biocompatibility: Meet ISO 10993-5 (In Vitro Cytotoxicity), ISO 10993-10 (Irritation and Skin Sensitization) standards.	"The battery of testing was performed to, and passed." (Implicitly, the device met these standards).
Electrical Safety: Meet IEC 60601-1-2, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57 standards.	"Electrical safety and Eye safety testing was performed to, and passed." (Implicitly, the device met these standards).
Eye Safety: Meet IEC 62471 standard.	"Eye safety testing was performed to, and passed." (Implicitly, the device met these standards).
Software Verification and Validation: Meet all software requirement specifications and mitigate all software hazards to acceptable risk levels (consistent with moderate level of concern).	"demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels."
Clinical Performance (Inferred from comparison to predicates): Perform hair reduction consistent with the intended use as an over-the-counter device.	"Performance data supports that the device is safe and as effective as the predicate device for its intended use." (This is a general statement, not a specific performance metric).

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

The document does not specify a sample size for a clinical test set for hair removal efficacy. The performance data presented focuses on non-clinical testing (biocompatibility, electrical safety, eye safety, software verification).

Sample Size for Non-Clinical Tests: Not explicitly stated (e.g., number of units tested for electrical safety).
Data Provenance: The document is a 510(k) submission, typically containing test reports from the manufacturer. The location of the manufacturer is Shenzhen, Guangdong, China. The document does not indicate whether the data is retrospective or prospective for any clinical studies, as no clinical studies with human subjects are detailed.

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

This information is not applicable or provided in the document as it focuses on non-clinical engineering and safety aspects, not a clinical study requiring expert assessment of outcomes like hair reduction or disease diagnosis. There is no mention of ground truth establishment by experts for the performance data presented.

4. Adjudication method for the test set

This information is not applicable or provided as there is no human-centric clinical test set requiring adjudication.

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

This information is not applicable. The device is an IPL hair removal device for direct consumer use, not an AI-assisted diagnostic imaging tool that would involve human readers (e.g., radiologists). There is no mention of an MRMC study or AI assistance for human readers.

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

This information is not applicable. The device is a physical IPL hair removal device, not an algorithm. Its operation involves a user directly applying it.

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

For the non-clinical performance data (biocompatibility, electrical safety, eye safety, software V&V), the "ground truth" is defined by established international and national standards (e.g., ISO 10993, IEC 60601, IEC 62471). The device is tested against these predefined safety and performance criteria.

8. The sample size for the training set

This information is not applicable. As a physical IPL device without an AI component that learns from data, there is no "training set" in the context of machine learning.

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

This information is not applicable for the same reason as point 8.

Summary

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December 20, 2021

Shenzhen Beauty Every Moment intelligent electric Co., Ltd. % Rain Yip Registered Engineer Feiying Drug & Medical Consulting Technical Service Group Contact Address

Re: K211185

Trade/Device Name: IPL Home Use Hair Removal Device 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 19, 2021 Received: November 22, 2021

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.

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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 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-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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K21185

Device Name

IPL Home Use Hair Removal Device, Model(s): D-1150, D-1171, D-1153, D-1156, D-1126, D-1178, D-1187

Indications for Use (Describe)

IPL Home Use 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)

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510(k) Summary

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

Date: 2021-12-17

I. Submitter

Shenzhen Beauty Every Moment intelligent electric Co.,Ltd. Rm. 501, Bldg. 4, Haoer Jiashitai Technology Park. Fengtang Avenue No. 164, Heping Community, Fuhai Street, Bao'an District, Shenzhen, Guangdong, China Post code: 518100 Tel .: +86 755 3325 3598

LUO HUAJUN Certification enginner Tel: +86 755 3325 3598 Email: 309024340@qq.com

II. Device

Name of Device: IPL Home Use Hair Removal Device Model(s): D-1150, D-1171, D-1153, D-1155, D-1156, D-1126, D-1178, D-1187 Common or Usual Name: Light Based Over-The-Counter 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

Manufacturer	Predicate Device	510(k) Number	Approval Date
ShenzhenTechnology Co., Ltd.	BosidinIPL Home Use Hair RemovalDevice/D-1128 (Primary)	K192432	Nov. 08, 2019
CyDen Limited.	iPulse SmoothSkin GoldHair Removal System	K160968	Apr.04, 2016

IV. Device Description

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device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.

V. Indications for Use

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

VI. Comparison of Technological Characteristics With the Predicate Device

The IPL Home Use 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 Home Use Hair Removal Device may be found substantially equivalent to its predicate device.

IPL Home Use Hair Removal Device is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance:

ComparisonElements	Subject Device	Predicate Device
		K192432(Primary)	K160968
K Number	Pending	K192432	K160968
Trade name	IPL Home Use Hair RemovalDevice/D-1150, D-1171, D-1153,D-1155, D-1156, D-1126, D-1178,D-1187	IPL Home Use HairRemoval Device/D-1128	iPulse SmoothSkinGold Hair RemovalSystem
Wavelengthrange	Regular window: 530-1100nm,590-1100nmFilter window: 600-1100nm	510-1100nm	510-1100nm
Energymedium	Xenon Arc Flashlamp	Xenon ArcFlashlamp	Xenon ArcFlashlamp
Energy density	2.0~4.5 J/cm²	2.0~4.0 J/cm²	3~6 J/cm²
Spot size	Regular window: 3.8cm², 3.6cm²,3.0cm², 1.0cm², 2.0cm², 1.9cm²,1.8cm²,Filter window: 3.0cm², 2.0cm²	4.5, 2.0, 2.5cm²	3 (3cm by 1cm)

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Comparison		Predicate Device
Elements	Subject Device	K192432(Primary)	K160968
Pulse duration	7.5~12ms	7.5-14.5ms	2-10ms
Pulsing control	Finger switch	Finger switch	Finger switch
Delivery device	Direct illumination to tissue	Direct illuminationtissue	Direct illuminationtissue
Indicationforuse/Intendeduse	IPL HomeUse Hair RemovalDevice isan over-the-counterdevice intended for removal ofunwanted body and/or facial hair.	IPL Home Use HairRemoval Device isan over-the-counterdevice intended forremovalofunwantedbodyand/or facial hair.	TheiPulseSmoothSkin GoldHairRemovalSystem is indicatedfor the removal ofunwanted hair. TheiPulse SmoothskinGold is alsoindicated for thepermanentreduction in hairregrowth, definedas the long-term,stable reduction inthe number of hairsregrowingwhenmeasured at 6, 9and 12 months afterthe completion of atreatment regime.
Locationforuse	OTC	OTC	OTC

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 devic4 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

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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

3) Eye Safety

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.

Summary

Based on the above performance as documented in this application, the subject device IPL Home Use 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 Home Use 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.