Home Use Hair Removal Device/T1, T2, T3

• K Number: K172883
• Device Name: Home Use Hair Removal Device/T1, T2, T3
• Manufacturer: Shenzhen Mareal Tech Co., Ltd
• Date Cleared: 2018-02-12 ( 144 days)
• Product Code: OHT
• Regulation Number: 878.4810

Intended Use

The Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted hair from small areas such as, but not limited to, underarm and facial hair below the chin line and large areas such as legs, in patients with Fitzpatrick Skin Phototypes I-V.

Device Description

The 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 IPL technology. And it consists of IPL main device and AC adapter, and a detachable lamp cap located in the IPL main device which is the source of optical radiation, namely a Xenon flashlamp. The Home Use Hair Removal Device includes three models, T1, T2 and T3. All three models are exactly the same with the exception of the LCD display contents (mainly as the symbol of treatment level). T1 and T3 both adopt shape identification to display the treatment levels, which T1 adopts fan-shaped display and T3 adopts rectangle-shaped display. And T2 direct adopts digital symbol to display treatment levels.

Predicate Devices

K161428, K160968

Reference Devices

No reference devices were used in this submission.

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, and the device description focuses on IPL technology and display variations.

Therapeutic

No

The device is intended for hair removal/reduction, which is a cosmetic purpose and generally not considered a therapeutic function that alleviates or cures a disease or medical condition.

Diagnostic

No

The device is intended for hair removal, which is a cosmetic purpose, not for diagnosing any medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of an "IPL main device and AC adapter, and a detachable lamp cap... which is the source of optical radiation, namely a Xenon flashlamp." This indicates the device includes significant hardware components for delivering the intended therapy.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The Home Use Hair Removal Device uses light-based technology (IPL) to physically remove unwanted hair from the skin. It does not perform any tests on biological samples.
• Intended Use: The intended use is for hair removal, not for diagnosing or monitoring any medical condition.

The description clearly indicates a device for cosmetic/personal use involving direct application of light to the skin, which falls outside the scope of In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted hair from small areas such as, but not limited to, underarm and facial hair below the chin line and large areas such as legs, in patients with Fitzpatrick Skin Phototypes I-V.

Product codes

OHT

Device Description

The 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 IPL technology. And it consists of IPL main device and AC adapter, and a detachable lamp cap located in the IPL main device which is the source of optical radiation, namely a Xenon flashlamp.

The Home Use Hair Removal Device includes three models, T1, T2 and T3. All three models are exactly the same with the exception of the LCD display contents (mainly as the symbol of treatment level). T1 and T3 both adopt shape identification to display the treatment levels, which T1 adopts fan-shaped display and T3 adopts rectangle-shaped display. And T2 direct adopts digital symbol to display treatment levels.

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

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-the-counter / 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)

1. Biocompatibility Testing:
   The biocompatibility evaluation for the body-contacting components of the Home Use Hair Removal 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 Eve 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, Home Use Hair Removal Device was found to have a safety and effectiveness profile that is similar to the predicate device.

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

Not Found

Predicate Device(s)

K161428, K160968

Reference Device(s)

No reference devices were used in this submission.

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

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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.

February 12, 2018

Shenzhen Mareal Tech Co., Ltd % Rain Yip Official Correspondent Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center Guimiao Road Shenzhen, 518000 Cn

Re: K172883

Trade/Device Name: Home Use Hair Removal Device/T1, T2, T3 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 12, 2018 Received: January 16, 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, 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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jennifer R. Stevenson -S3

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) K172883

Device Name Home Use Hair Removal Device

Indications for Use (Describe)

The Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted hair from small areas such as, but not limited to, underarm and facial hair below the chin line and large areas such as legs, in patients with Fitzpatrick Skin Phototypes I-V.

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: 2017.09.16

I. Submitter

Shenzhen Mareal Tech Co., Ltd 403A Block, Xinlong Technology Park, No.50 Fengtang Road, Xintian Community, Fuyong Town, Bao'an District, Shenzhen, China

Tel.: [phone] Tax: [phone]

Libin Liu Tel: [phone] Email: [e-mail]

II. Device

Name of Device: Home Use Hair Removal Device Common or Usual Name: Light Based Over-The-Counter Hair Removal Regulation Description: 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

• 1 ) 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

2 ) No reference devices were used in this submission.

IV. Device Description

The 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 IPL

4

technology. And it consists of IPL main device and AC adapter, and a detachable lamp cap located in the IPL main device which is the source of optical radiation, namely a Xenon flashlamp.

The Home Use Hair Removal Device includes three models, T1, T2 and T3. All three models are exactly the same with the exception of the LCD display contents (mainly as the symbol of treatment level). T1 and T3 both adopt shape identification to display the treatment levels, which T1 adopts fan-shaped display and T3 adopts rectangle-shaped display. And T2 direct adopts digital symbol to display treatment levels.

V. Indications for Use

The Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted hair from small areas such as, but not limited to, underarm and facial hair below the chin line and large areas such as legs, in patients with Fitzpatrick Skin Phototypes I-V.

VI. Comparison of Technological Characteristics With the Predicate Device

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

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

1. K161428, "PerfectSmooth", manufactured by "Shen CosBeauty Co., Ltd" in Guangdong, China

2. K160968, "iPulse SmoothSkin Gold Hair Removal System ", manufactured by "CyDen Limited" in Wales, UK

The following table shows similarities and differences of use, design, material, safety and effectiveness between the subject device and predicate devices.

Information for predicate device was obtained from publicly available sources, including the 510(k) Summary and device instruction manual. A technical comparison to the predicate is provided below:

| 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
Comparison
Elements	Subject Device	Predicate Device 1	Predicate Device 2
Trade name	Home Use Hair
Removal Device	PerfectSmooth	iPulse SmoothSkin
Gold Hair Removal
System
Energy medium	Xenon Arc Flashlamp	Xenon Arc Flashlamp	Xenon Arc Flashlamp
Pulse duration	11-13 milliseconds	11-13 milliseconds	2-10 milliseconds
Energy density	4.8 J/cm2	4.7J/cm2	3~6 J/cm2
Spot size	3.9 cm2	4.5 cm2	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	The Home Use Hair
Removal 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,
with Fitzpatrick Skin
Phototypes I-V.	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

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VII.Performance Data

The following performance data were provided in support of the substantial equivalence determination.

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1) Biocompatibility Testing

The biocompatibility evaluation for the body-contacting components of the Home Use Hair Removal 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 Eve 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, 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 Home Use Hair Removal Device is to be concluded substantial equivalent to its predicate devices.