Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)

K161434 · Li-Tek Electronics Technologies · OLP · Sep 28, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K161434
• Device Name: Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)
• Applicant: Li-Tek Electronics Technologies
• Product Code: OLP · General, Plastic Surgery
• Decision Date: Sep 28, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) is intended for over-the-counter use. LED functional mode - To emit energy in the blue and red region of the spectrum, specifically to treat mild to moderate acne on the face. - To emit energy in the blue region of the spectrum to treat mild to moderate inflammatory acne. Vibrating massage functional mode As an electrically powered device intended for medical purposes to relieve minor aches and pains.

Device Story

Handheld, battery-operated facial aesthetic device (Model: UI-200) featuring two primary modes: LED light irradiation and vibrating massage. LED mode emits red (630±10nm) and blue (415±10nm) light to treat acne. Vibrating massage mode uses a stainless steel contactor to provide mechanical vibration for pain relief. Operated by lay users in home settings. Users select modes via a button; device provides visual indicators for battery, mode, and intensity. Output affects skin surface; LED energy targets acne-causing factors, while vibration provides therapeutic massage. Benefits include non-invasive acne management and minor pain relief.

Clinical Evidence

Bench testing only. Includes electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance testing (IEC 60601-2-57). Waveform testing verified vibration pulse parameters. A lay-user study (n=not specified) demonstrated 100% success in self-selection and device operation based on labeling and manual instructions.

Technological Characteristics

ABS plastic housing with stainless steel contactor. Powered by 3.7V 1000mAh Li-battery. LED light source (Red 630nm, Blue 415nm). Mechanical vibration via internal motor. Type BF applied part. Complies with IEC 60601-1, IEC 60601-2-57, IEC 60601-1-2, ISO 10993-5, and ISO 10993-10. Portable form factor (3.7" x 7.6" x 2.8").

Indications for Use

Indicated for OTC use by individuals with mild to moderate acne on the face or mild to moderate inflammatory acne. Also indicated for relief of minor aches and pains.

Regulatory Classification

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.

Predicate Devices

• Ultra Renew Plus (K132833)
• Tanda Mini Skincare System (K124042)
• Pulsaderm Acne Device (K161941)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines connecting them, resembling a bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 28, 2017

Li-Tek Electronics Technologies c/o Shiling Li Guangzhou KunSBo Managing Consultancy Co., Ltd Building H, No 199 Kezhu Road, Guangzhou Science City Guangzhou, Guangdong Province, China 510000

Re: K161434

Trade/Device Name: Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) 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: OLP Dated: August 23, 2017 Received: September 1, 2017

Dear Shiling Li:

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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Jennifer R. Stevenson -53 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) K161434

#### Device Name

Photon Vibrating Massage Facial Aesthetic Device , Model: UI-200

Indications for Use (Describe)

The Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) is intended for over-the-counter use. LED functional mode

- To emit energy in the blue and red region of the spectrum, specifically to treat mild to moderate acne on the face.
- To emit energy in the blue region of the spectrum to treat mild to moderate inflammatory acne.

Vibrating massage functional mode

As an electrically powered device intended for medical purposes to relieve minor aches and pains.

| 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

## Date of the summary prepared: September 28, 2017

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

## 1. Submitter's Information

- � 510(k) Owner's Name: Li-Tek Electronics Technology Corporation
- Establishment registration number: Applying �
- Address: No. 8~13, Industrial Park of Jinshagang, Shixia village, Dalang town, Dongguan � city, Guangdong, China
- Phone: [phone] �
- Fax: [phone] �
- Contact Person (including title): Barry Yuan (Quality Director) �
- � E-mail: [e-mail]

#### 2. Application Correspondent

- � Contact person: Mr. Jet Li
- Company name: Guangzhou KunSBo Managing Consultancy Co., Ltd �
- Tel: [phone] �
- � Email: [e-mail]

#### 3. Subject Device Information

| ◆ | Trade Name: | Photon Vibrating massage Facial Aesthetic Device, Model<br>UI-200 |
|---|----------------------|------------------------------------------------------------------------------|
| ◆ | Common Name: | Acne Light Therapy System |
| ◆ | Classification name: | Over-the-counter powered light based laser for acne;<br>Therapeutic massager |
| ◆ | Review Panel: | General & Plastic Surgery, Physical Medicine |

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- OLP, ISA Product Code: �
- � Regulation Class: 2
- � Regulation Number: 878.4810, 890.5660

#### Predicate Device Information a)

| Sponsor | Accord Media | Syneron Beauty Inc. | NutraLuxe MD, LLC |
|----------------------|--------------------|-------------------------------|--------------------------|
| Device Name | Ultra Renew Plus | Tanda Mini Skincare<br>System | Pulsaderm Acne<br>Device |
| 510(k) Number | K132833 | K124042 | K161941 |
| Product Code | OLP, OHS, ISA | OLP | OLP |
| Regulation<br>Number | 878.4810, 890.5660 | 878.4810 | 878.4810 |
| Regulation Class | 2 | 2 | 2 |

#### 4. Device Description

Photon Vibrating massage Facial Aesthetic Device, Model: UI-200 is a device provided with two operation functions: Vibrating massage and LED light irradiation. The product provided with internal battery and it can be charged by external adaptor.

For LED light irradiation functional, the device provides with two LED irradiation modes: Blue Light working Mode, Blue and Red Light working Mode, which can be switched by Mode button. When the device works in red and blue light working mode, the device provides spectral emission with LED red light (630±10nm) and blue light (415±10nm). In blue light working mode, the device only provide LED blue light output (415±10nm) by the LED lamp module in treatment head.

When the device works in Vibrating massage mode, the vibration can be provided on the stainless steel contactor in treatment head and can provide vibrating massage to facial skin.

#### 5. Intended Use / Indications for Use

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The Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) is intended for over-the-counter use.

#### LED functional mode

- To emit energy in the blue and red region of the spectrum, specifically to treat mild to moderate acne on the face.

- To emit energy in the blue region of the spectrum to treat mild to moderate inflammatory acne.

#### Vibrating massage functional mode

As an electrically powered device intended for medical purposes to relieve minor aches and pains.

#### 6. Design

Photon Vibrating massage Facial Aesthetic Device, Model: UI-200 is a device provided with two operation functions: Vibrating massage and LED light irradiation. The product provided with internal battery and it can be charged by external adaptor.

For LED light irradiation functional, the device provides with two LED irradiation modes: Blue Light working Mode, Blue and Red Light working Mode, which can be switched by Mode button. When the device works in red and blue light working mode, the device provides spectral output with LED red light (630±10nm) and blue light (415±10nm). In blue light working mode, the device only provide LED blue light output (415±10nm) by the LED lamp module in treatment head.

When the device works in Vibrating massage mode, the vibration can be provided on the stainless steel contactor in treatment head and can provide vibrating massage to facial skin. For aforementioned three operation modes, they can only operate separately.

#### 7. Materials

There is one of patient directly component in the subject device as the following list.

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| Device Requiring<br>Biocompatibility | Component | Category<br>(ISO 10993-1) | (ISO 10993-1) |
|------------------------------------------------------------|-----------------|------------------------------------|--------------------------------|
| stainless steel<br>treatment head for<br>vibrating massage | Stainless steel | Surface-contacting<br>device: skin | Maximum 2 hours<br>(< 24hours) |

The Nature of body contact is surface-skin contact. And the contact duration is less than 24 hours. According to Table 1 - Initial evaluation tests for consideration in ISO 10993-1, the applicable biological effect is:

- ◆ Cytotoxicity
- ◆ Sensitization
- ◆ Irritation or intracutaneous reactivity

## 8. Physical characteristics

| Table I | |
|----------------------------------------------|-------------------------------------------------------------------------------------------------|
| Basic Unit Characteristics | |
| Method of Line Current Isolation | Type BF Applied Part |
| Compliance* with 21 CFR 898 | Yes |
| Main Unit Weight | 180g |
| Main Unit Dimension | 3.7" L x 7.6" W x 2.8" D |
| Housing Materials of main unit | Housing made from ABS plastic and output contacts<br>made from stainless steel. |
| Indicator | Indicates low battery, working mode information,<br>intensity level for vibrating massage mode. |
| Time Range (minutes) | 1-20 mins |
| Environment for operation | Temperature: 5°C~40°C<br>Humidity: ≤ 80% |
| Compliance with Voluntary<br>Standards | Yes<br>Comply with IEC 60601-1, IEC 60601-2-57, IEC<br>60601-1-2 |
| Patient leakage current | Comply with IEC 60601-1 |
| Power Source | 3.7V 1000mAh Li battery |
| Software/Firmware/Microprocessor<br>Control? | Yes |

Table I

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| | Humidity: ≤ 80% |
|-------------------------|-------------------------------------------------------------|
| Environment for Storage | Temperature: 0 ~ 45°C<br>Humidity: ≤ 93% RH |
| Biocompatibility | Compliance with ISO10993-5 and ISO10993-10<br>requirements. |
| Electrical Safety | Comply with IEC 60601-1, and IEC60601-2-57 |
| EMC | Comply with IEC 60601-1-2 |

1) For Vibrating massage Mode:

Table II Vibration intensity level Level 1 Level 2 Level 3 Level 4 Level 5 on output contactor Frequency for 2.98MHz 2.96MHz 2.97MHz 2.97MHz 2.97MHz ultrasonic wave Vibrator massage 84 us 105 us 144 us 124 us 164 us pulse Vibrator massage 196.3 Hz 195.5 Hz 194.7Hz 193.9 Hz 193.2 Hz frequency Output Power 0.16W

## 2) For LED light mode: Blue mode and Red Mode

| Table III | |
|-------------------|-------------------------------|
| LED Wavelengths | Red: 630±10nm, Blue: 415±10nm |
| LED power density | Blue: 22 mW/cm² |
| | Red: 7.5 mW/cm² |

## 10. Test Summary

Photon Vibrating massage Facial Aesthetic Device, Model: UI-200 has been evaluated the safety and performance by lab bench testing as following:

- ◆ Electrical safety test according to IEC 60601-1 Edition 3.0: 2005+A1:2012 and IEC60601-2-57 Edition 1.0: 2011

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- � Electromagnetic compatibility test according to IEC 60601-1-2 Edition 4.0: 2014 standard
- � 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 waveform test report has also been conducted to verify the vibration massage pulse's parameters of the device.

## 11. Usability study and self-selection study summary

A lay-user study and self-selection study was conducted and oversight to determine if lay users could read the product labeling and then self assess if the device would be appropriate for them to use. Study data was collected and demonstrated that the intended users of the device could successfully follow the instructions and use the device as intended. The performance data supplied in this 510(k) demonstrated that 100% of lay users were able to properly self-select themselves using the box labeling and all lay users were able to properly use the device by reading instructions in the user manual without any assistance. In summary, the conclusion was that an average lay user can read and comprehend correctly the user manual and package labeling.

## 12. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, and intended use of Photon Vibrating massage Facial Aesthetic Device, Model: UI-200 is substantially equivalent to the predicate devices quoted above.

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

| Elements of<br>Comparison | Subject Device | Predicate Device | | Remark |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| | | | | |
| Device Name<br>and Model | Photon Vibrating massage<br>Facial Aesthetic Device,<br>Model: UI-200 | Tanda Mini Skincare System | Pulsaderm Acne Device | -- |
| 510(k) Number | Applying | K124042 | K161941 | -- |
| Product Code | OLP, ISA | OLP | OLP | -- |
| Manufacturer | Li-Tek Electronics | Syneron Beauty Inc. | NutraLuxe MD, LLC | -- |
| Elements of<br>Comparison | Subject Device | Predicate Device | Remark | |
| | | | | |
| | Technologies | | | |
| Intended Use | The Photon Vibrating<br>massage Facial Aesthetic<br>Device (Model: UI-200) is<br>intended for<br>over-the-counter use.<br>LED functional mode<br>- To emit energy in the blue<br>and red region of the<br>spectrum, specifically to<br>treat mild to moderate acne<br>on the face.<br>- To emit energy in the blue<br>region of the spectrum to<br>treat mild to moderate<br>inflammatory acne.<br>Vibrating massage<br>functional mode<br>As an electrically powered<br>device intended for medical<br>purposes to relieve minor<br>aches and pains. | The Tanda Mini Skincare<br>System is generally indicated<br>to treat dermatological<br>conditions. Specifically, blue<br>light modules are indicated to<br>treat mild to moderate<br>inflammatory acne. | Pulsaderm Acne Device is<br>intended to emit energy in the<br>red and blue region of the<br>spectrum, specifically<br>indicated to treat mild to<br>moderate acne on the face.<br>SE<br>Note 1 | |
| Basic Unit Characteristics | | | | |
| Power<br>Source(s) | 3.7V 1000mAh Li battery | Battery operated | SE | |
| Method of Line<br>Current<br>Isolation | Type BF Applied Part | Type BF Applied Part | SE | |
| Weight | 180g | -- | SE<br>Note 2 | |
| Dimensions | 3.7" L x 7.6" W x 2.8" D | -- | SE<br>Note 2 | |
| Housing<br>Materials and<br>Construction | Housing made from ABS<br>plastic and output contacts<br>made from stainless steel | -- | SE<br>Note 2 | |
| Elements of<br>Comparison | Subject Device | Predicate Device | | Remark |
| Output Specifications | | | | |
| Energy Type | LED | LED | LED | SE |
| LED light<br>Wavelengths | Red: 630 ± 10 nm,<br>Blue: 415 ± 10 nm | Blue:414nm ± 6 nm | Red: 630 ± 5 nm,<br>Blue: 415 ± 5 nm | SE<br>Note 3 |
| LED light Power<br>Density | Blue: 22 mW/cm²<br>Red: 7.5 mW/cm² | Blue:22.4 mW/cm² | Blue: 20 mW/cm²<br>Red: 5 mW/cm² | SE<br>Note 4 |
| Additional Features | | | | |
| Environment for<br>Operating | Temperature: 5 ~ 40°C<br>Humidity: ≤ 80% | -- | | SE<br>Note 5 |
| Environment for<br>Storage | Temperature: 0 ~ 45°C<br>Humidity: ≤ 93% RH | -- | | SE<br>Note 5 |
| Biocompatibility | Compliance with<br>ISO10993-5 and<br>ISO10993-10 requirements. | Compliance with ISO10993-5<br>and ISO10993-10<br>requirements. | Compliance with ISO10993-5<br>and ISO10993-10<br>requirements. | SE |
| Electrical<br>Safety | Comply with IEC 60601-1<br>and IEC60601-2-57 | Comply with IEC 60601-1 | Comply with IEC 60601-1 | SE |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |

#### 1) LED functional modes

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## Comparison in Detail(s):

## Note 1 (Intended Use):

For LED irradiation modes, we selected K124042 as predicate device to do substantial equivalence discussion for blue light mode of the subject device, while choose K161941 as the second predicate device to do substantial equivalence discussion for the blue and red light mode.

Although there is minor difference for the expressions of intended use between subject device and predicate devices, they all indicated the same indication for use for each working mode, respectively.

## Note 2 (Weight, Dimensions, Materials):

These data would be different for different devices because the internal circuit design and components choosing are different. But weight and dimensions won't affect the safety and

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effectiveness of the device since it still belongs to portable device and complied with IEC60601-1. So it would not affect safety and effectiveness of subject device.

## Note 3 (LED light Wavelengths):

The LED light wavelengths of the subject device are the same as the predicate device. The wavelengths of blue light mode, comparing between the subject device and K124042, are 415 nm and 414 nm, which are substantially equivalence. The wavelengths of red light, comparing to K161941, are 630 nm, which are substantially equivalence. Therefore, both of blue light wavelength and red light wavelength are the subject device and predict device.

## Note 4 (LED light Power Density):

For the LED irradiation mode with red light and blue right, the power density of red light in the subject device is 7.5 mW, but this minor difference of power density would not change lots of LED energy irradiation on the face; and the device pass the testing of IEC60601-2-57, it's safety would not be affected. Therefore, the minor difference of LED power density would not affect the safety and effectiveness of subject device.

## Note 5 (Environment for Operating and storage):

These data is to specify the condition of working, transportation and storage. The temperature, RH can be claimed with different condition, and the device pass the testing of IEC60601-1-11. So it can be deemed as the substantially equivalence.

| Elements of<br>Comparison | Subject Device | Remark | Remark |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Device Name<br>and Model | Photon Vibrating massage Facial<br>Aesthetic Device, Model: UI-200 | Ultra Renew Plus | -- |
| 510(k) Number | Applying | K132833 | -- |
| Product Code | OLP, ISA | OLP, OHS, ISA | -- |
| Manufacturer | Li-Tek Electronics Technologies | Accord Media | -- |
| Intended Use | The Photon Vibrating massage Facial<br>Aesthetic Device (Model: UI-200) is<br>intended for over-the-counter use.<br>LED functional mode<br>- To emit energy in the blue and red region | The Accord Media Ultra Renew Plus is<br>intended to be used:<br>LED functional mode<br>- To emit energy in the red and blue region of<br>the spectrum, specifically to treat mild to | SE |
| Elements of<br>Comparison | Subject Device | Remark | Remark |
| | of the spectrum, specifically to treat mild to moderate acne on the face.<br>- To emit energy in the blue region of the spectrum to treat mild to moderate<br>inflammatory acne.<br>Vibrating massage functional mode<br>As an electrically powered device intended for medical purposes to relieve minor aches and pains. | - To emit energy in the red region of the spectrum for the treatment of periorbital wrinkles.<br>Ultrasonic functional mode<br>As an electrically powered device intended for medical purposes to relieve minor aches and pains. | |
| Basic Unit Characteristics | | | |
| Power<br>Source(s) | 3.7V 1000mAh Li battery | Battery operated | SE |
| Method of Line<br>Current<br>Isolation | Type BF Applied Part | Type BF Applied Part | SE |
| Weight | 180g | -- | SE<br>Note 1 |
| Dimensions | 3.7" L x 7.6" W x 2.8" D | -- | SE<br>Note 1 |
| Housing<br>Materials and<br>Construction | Housing made from ABS plastic and output contacts made from stainless steel. | -- | SE<br>Note 1 |
| Output Specifications | | | |
| Vibrating<br>massage<br>Frequency | 3MHz ± 5% | 3MHz ± 5% | SE<br>Note 2 |
| Additional Features | | | |
| Environment for<br>Operating | Temperature: 5 ~ 40°C<br>Humidity: ≤ 80% | -- | SE<br>Note 3 |
| Environment for<br>Storage | Temperature: 0 ~ 45°C<br>Humidity: ≤ 93% RH | -- | SE<br>Note 3 |
| Elements of | Subject Device | Remark | Remark |
| Comparison | | | |
| Biocompatibility | All user directly contacting materials are<br>compliance with ISO10993-5 and<br>ISO10993-10 requirements. | All user directly contacting materials are<br>compliance with ISO10993-5 and ISO10993-10<br>requirements. | SE |
| Electrical<br>Safety | Comply with IEC 60601-1 and<br>IEC60601-2-57 | Comply with IEC 60601-1 | SE |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |

#### 2) Vibrating massage functional mode

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## Comparison in Detail(s):

## Note 1 (Weight, Dimensions, Materials):

These data would be different for different devices because the internal circuit design and components choosing are different. But weight and dimensions won't affect the safety and effectiveness of the device since it still belongs to portable device and complied with IEC60601-1. So it would not affect safety and effectiveness of subject device.

## Note 2 (Vibrating massage Frequency):

Both of the ultrasound frequency and the technology principle are the same to the subject device and the predicate device. For the technology principle, the design of both devices is same, and they meant to be pulsed so that therapeutic vibration of the device head at lower frequencies provides massage. Therefore, the subject device and predicate devices are substantially equivalence in Vibrating massage Mode.

#### Note 3 (Environment for Operating and storage):

These data is to specify the condition of working, transportation and storage. The temperature, RH can be claimed with different condition, and the device pass the testing of IEC60601-1-11. So it can be deemed as the substantially equivalence.

#### Finial Conclusion:

The subject device " Photon Vibrating massage Facial Aesthetic Device, Model: UI-200" is substantial Equivalence to all predicate devices.