K Number

Device Name

Home Use IPL Beauty Device

Manufacturer

Shenzhen Mismon Technology Co., Ltd

Date Cleared

2018-03-20

(77 days)

Product Code

OHT

Regulation Number

878.4810

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K161428, K160968

Reference Devices

Considering the context, the phrase "Reference Device(s)" does not appear immediately followed by K/DEN numbers. The prompt then asks for numbers that "appear in the text". The section "Predicate Device(s)" contains numbers, and while the prompt asks for "Reference Device(s)", this section is the closest match in terms of content structure from which to extract K/DEN numbers. Extracting these from "Predicate Devices" may be incorrect as per the prompt but there is no specific "Reference Devices" section with K/DEN numbers. If the intent was to find K/DEN numbers anywhere else in the document, clarification would be needed. Based on the strict interpretation of the prompt, as "Reference Device(s)" is Not Found, the answer should be empty.

The prompt requires to identify the Reference Device(s) K/DEN number.
Looking at the document provided:

There is a section titled "Predicate Device(s)". This section lists: K161428, K160968.
There is a section titled "Reference Device(s)". This section lists: Not Found.

Since the prompt specifically asks for "Reference Device(s) K/DEN number" and the "Reference Device(s)" section states "Not Found", there are no K/DEN numbers to list under that category.

If the prompt intended to ask for Predicate Devices, the answer would be K161428, K160968. However, it explicitly asks for "Reference Device(s)".

Therefore, the correct answer based on the provided text is an empty list as requested from the text.

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard IPL hair removal device with no mention of AI or ML capabilities in its operation, device description, or performance studies.

Therapeutic

No
The intended use of the device is for hair removal, which is typically considered a cosmetic or aesthetic purpose, not a therapeutic treatment for a medical condition.

Diagnostic

The "Intended Use" section states that the device is "intended for removal of unwanted hair," which is a therapeutic or cosmetic purpose, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description explicitly states it includes hardware components such as a main body, power adapter, and a Xenon flashlamp. The performance studies also detail testing related to biocompatibility, electrical safety, and eye safety, which are hardware-related aspects. While software verification and validation are mentioned, the device is clearly not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "removal of unwanted hair". This is a cosmetic or aesthetic purpose, not a diagnostic one. IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Device Description: The device uses IPL (Intense Pulsed Light) technology to target hair follicles. This is a physical process applied externally to the body, not a test performed on a biological sample.
Lack of Diagnostic Function: There is no mention of the device analyzing biological samples, detecting biomarkers, or providing any information related to a medical condition or disease.
Performance Studies: The performance studies focus on safety (biocompatibility, electrical safety, eye safety) and usability, which are relevant for a consumer-use device, but not typical for demonstrating the analytical or clinical performance of an IVD.

In summary, the Home Use IPL Beauty Device is a personal care or cosmetic device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

OHT

Device Description

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 3.9cm squared and MS-206B is 3.0 cm squared, as well as the energy density of the both models is 5.5 J/cm2.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

underarm, facial hair below the chin line, legs (areas of unwanted hair)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

OTC / Home Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Biocompatibility Testing:
- Evaluation for body-contacting components in accordance with "Use of International Standard ISO 10993-1."
- Passed ISO 10993-5:2009/(R)2014 (Tests for In Vitro Cytotoxicity).
- Passed ISO 10993-10:2010 (Tests for Irritation and Skin Sensitization).
Electrical Safety and Eye Safety:
- Passed IEC 60601-1-2 (Electromagnetic compatibility).
- Passed IEC 60601-1 (General requirements for basic safety and essential performance).
- Passed IEC 60601-1-11 (Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment).
- Passed IEC 60601-2-57 (Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use).
Eye Safety:
- Passed IEC 62471 (Photobiological safety of lamps and lamp systems).
Software Verification and Validation:
- Software documentation consistent with a moderate level of concern was submitted.
- System validation testing demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
OTC Usability Study:
- Enrolled a total of 20 participants.
- Conducted to gather data from laypersons regarding labeling understanding (what the device is, what it does, how it works).
- Completed successfully with no issues or negative comments.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K161428, K160968

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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

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

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 )
----------------------------------------------------------

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 CosBeauty
Co., Ltd	Perfectsmooth	K161428	March 23, 2017
CyDen Limited	iPulse SmoothSkin Gold Hair
Removal 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

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.

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

| Comparison

Elements	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 Beauty
Device	PerfectSmooth	iPulse SmoothSkin
Gold Hair Removal
System
Comparison
Elements	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 to
tissue	Direct
illumination to
tissue	Direct
illumination to
tissue
Pulsing control	Finger switch	Finger switch	Finger switch
Indication
for
use/Intended use	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.	The PerfectSmooth 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.	The iPulse SmoothSkin
Gold Hair Removal
System is indicated for
the removal of
unwanted hair.
The iPulse Smoothskin Gold
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.
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.

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

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.