Home Use IPL Beauty Device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.

Device Description

The Home Use IPL Beauty 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 IPL technology. Of which, the Device includes MELSYA-M5 and MS-206B two models. Both have adopted the same structure design, consisting of Hair removal device main body and power adapter two parts, and a hair removal lamp located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is power from power adapter via an external power.

The difference of MELSYA-M5 and MS-206B two models is mainly the exception of appearance and spot size (the size of treatment window) which do not affect the intended use. The spot size of MELSYA-M5 is 3.9cm² and MS-206B is 3.0 cm², as well as the energy density of the both models is 5.5 J/cm2.

AI/ML Overview

The provided text is a 510(k) summary for the "Home Use IPL Beauty Device" and details its substantial equivalence to predicate devices. It covers various performance data but does not include a table of acceptance criteria and reported device performance for a hair removal efficacy study.

Here's an analysis of the available information:

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

Not provided in the document. The document discusses various safety and usability tests but does not present acceptance criteria or reported performance for hair removal efficacy directly. It broadly states, "Performance data supports that the device is safe and as effective as the predicate device for its intended use," but no specific metrics for hair removal are given in this summary.

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

Test set for OTC Usability Study: A total of 20 participants were enrolled.
Data Provenance: Not explicitly stated for the usability study. The manufacturer is Shenzhen Mismon Technology Co., Ltd, China.

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):

Not applicable / Not provided. The "OTC Usability Study" focused on layperson understanding of labeling, not on establishing a ground truth for device performance by experts.

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

Not applicable / Not provided. For the usability study, the focus was on gathering data from participants regarding their understanding, not on adjudication of results by experts.

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:

No, an MRMC comparative effectiveness study was not done. This device is a hair removal device, not an AI-powered diagnostic or imaging device where such a study would typically be performed.

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

Not applicable. This device is a direct-use consumer product, not an algorithm.

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

For the OTC Usability Study: The "ground truth" was related to whether participants understood the labeling and how the device works, measured by their responses and comments. This is a form of user feedback/understanding data, not clinical ground truth in the traditional sense of efficacy.

8. The sample size for the training set:

Not applicable / Not provided. This document does not describe a machine learning model with a training set.

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

Not applicable / Not provided. As there is no mention of a machine learning model or training set, this information is not relevant to the provided text.

In summary, the document details safety and usability testing, but does not provide specific performance data or a structured study on hair removal efficacy with acceptance criteria. Its primary focus for performance data mentioned is on biocompatibility, electrical safety, eye safety, software verification, and OTC usability, all of which were reported as "passed" or "completed successfully" without issues.

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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 20, 2018

Shenzhen Mismon Technology Co., Ltd % Rain Yip Registered Engineer Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center Guimiao Road. S Shenzhen, 518000 Cn

Re: K180016

Trade/Device Name: Home Use IPL Beauty 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: December 28, 2017 Received: January 2, 2018

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. 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm_for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K180016

Device Name Home Use IPL Beauty Device

Indications for Use (Describe)

Type of Use ( Select one or both, as applicable )
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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: 2017-12-28

I. Submitter

Shenzhen Mismon Technology Co., Ltd 2rd Floor, A2 Building, Zhengfeng Industrial Park, No.610 Fengtang Road, Fuyong Street, Bao'an District, Shenzhen, China

Tel.: +86 755 6681 6307 Tax: +86 755 8654 5582

Vicky Yang General Manager Tel: +86 158 1871 5190 Email: vicky@mismon.com

II. Device

Name of Device: Home Use IPL Beauty Device 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

The predicate devices are listed as below:

Manufacturer	Predicate Device	510(k) Number	Approval Date
Shen Zhen CosBeautyCo., Ltd	Perfectsmooth	K161428	March 23, 2017
CyDen Limited	iPulse SmoothSkin Gold HairRemoval System	K160968	April 04, 2016

IV. Device Description

The Home Use IPL Beauty 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 IPL

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technology. Of which, the Device includes MELSYA-M5 and MS-206B two models. Both have adopted the same structure design, consisting of Hair removal device main body and power adapter two parts, and a hair removal lamp located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is power from power adapter via an external power.

V. Indications for Use

VI. Comparison of Technological Characteristics With the Predicate Device

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

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

K161428, "PerfectSmooth", manufactured by "Shen CosBeauty Co., Ltd" in Guangdong, China
K160968, "iPulse SmoothSkin Gold Hair Removal System ", manufactured by "CyDen Limited" in Wales, UK

ComparisonElements	Subject Device	Predicate Device 1	Predicate Device 2
K Number	Pending	K161428	K160968
Common name	Light Based Over-The-Counter Hair Removal	Light Based Over-The-Counter Hair Removal	Light Based Over-The-Counter Hair Removal
Trade name	Home Use IPL BeautyDevice	PerfectSmooth	iPulse SmoothSkinGold Hair RemovalSystem
ComparisonElements	Subject Device	Predicate Device 1	Predicate Device 2
Energy medium	Xenon Arc Flashlamp	Xenon Arc Flashlamp	Xenon Arc Flashlamp
Pulse duration	9-11 milliseconds	11-13 milliseconds	2-10 milliseconds
Energy density	5.5 J/cm $^{2}$	4.7J/cm $^{2}$	3~6 J/cm $^{2}$
Spot size	MELSYA-M5: 3.9cm $^{2}$MS-206B: 3.0cm $^{2}$	4.5 cm $^{2}$	3 (3cm by 1cm)
Delivery device	Direct illumination totissue	Directillumination totissue	Directillumination totissue
Pulsing control	Finger switch	Finger switch	Finger switch
Indicationforuse/Intended use	Home Use IPL BeautyDevice is an over-the-counter device intendedfor removal ofunwanted hair such asbut not limited to smallareas such as underarmand facial hair belowthe chin line and largeareas such as legs.	The PerfectSmooth isan over-the-counterdevice intended forremoval of unwantedhair such as but notlimited to small areassuch as underarm andfacial hair below thechin line and large areassuch as legs.	The iPulse SmoothSkinGold Hair RemovalSystem is indicated forthe removal ofunwanted hair.The iPulse Smoothskin Goldis also indicated for thepermanent reduction inhair regrowth, definedas the long-term, stablereduction in the numberof hairs regrowingwhen measured at 6, 9and 12 months after thecompletion of atreatment regime.
Location for use	OTC	OTC	OTC

Information for predicate devices was obtained from publicly available sources, including the 510(k) Summary and device instruction manual.

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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 Home Use IPL Beauty 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

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Management Process, Document Issued on June 16, 2016", as recognized by FDA. The battery of testing was performed to, and passed, including:

ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices –Par t 5: Tests for In Vitro Cytotoxicity
ISO 10993-10:2010, 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 -- 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.

5) OTC Usability Study

An OTC Usability Study was enrolled a total of 20 participant and was conducted to provide a basis for the Company to gather data from the layperson relative to level of labellings understanding of what the device is, what the device does and how it works. This Study was completed successfully and the results were no any issues or negative comments.

Summary

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