Pobling MIITY 2

K163550 · Habalan Med & Beauty Co.,Ltd · NFO · Dec 20, 2017 · Neurology

Device Facts

• Record ID: K163550
• Device Name: Pobling MIITY 2
• Applicant: Habalan Med & Beauty Co.,Ltd
• Product Code: NFO · Neurology
• Decision Date: Dec 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Pobling MIITY 2 is intended for facial stimulation.

Device Story

Pobling MIITY 2 is a battery-powered, hand-held facial toning device. It delivers micro-current stimulation to healthy facial skin via the main unit head. The device features integrated heating (41°C ±3°C) and cooling (10°C ±3°C) functions, selectable via button. Operated by the user in a home or clinic setting, the device provides non-invasive facial stimulation. The healthcare provider or user observes the device's output performance (voltage/current) to ensure consistent stimulation. The device is intended to provide cosmetic facial toning benefits through electrical stimulation.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993: cytotoxicity, skin sensitization, skin irritation), and thermal safety testing for the heating/cooling functions.

Technological Characteristics

Hand-held, battery-powered facial toning device. Housing material: ABS. Output: 1 channel, direct current waveform. Features: heating/cooling, automatic shut-off, low-battery indicator. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11. Biocompatibility: ISO 10993 (tissue contacting <24 hours).

Indications for Use

Indicated for over-the-counter cosmetic use for facial stimulation in healthy individuals.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• NuFACE® Plus (K103472)
• NuSkin Facial Spa (K122711)

Submission Summary (Full Text)

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December 20, 2017

HABALAN Med & Beauty Co., Ltd c/o Peter Chung President Plus Global 300 Atwood Pittsburgh, Pennsylvania 15213

Re: K163550

Trade/Device Name: Pobling MIITY 2 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: December 7, 2017 Received: December 13, 2017

Dear Peter Chung:

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

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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 (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.

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.

Vivek J. Pinto -S

for Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K163550

Device Name Pobling MIITY 2

Indications for Use (Describe)

The Pobling MITY 2 is intended for facial stimulation and is indicated for over-the counter cosmetic use.

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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Image /page/3/Picture/0 description: The image shows the logo for HABALAN, with the words "Different Insight" underneath. The logo is in a bold, sans-serif font. The letters are all capitalized and connected to each other. The words "Different Insight" are in a smaller, sans-serif font.

# 510(k) Summary

Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92

### 1. Submitter's Information

- 1) Name : HABALAN Med & Beauty Co., Ltd
- 2) Address : 907, 219, Gasandigital 1-ro, Geumcheon-gu, Seoul, KOREA
- 3) Contact person : Mr. Peter Chung

300 Atwood Street Pittsburgh, PA 15213, USA

Tel : [phone]

- 4) Date prepared : December, 05, 2016
#### 2. Device Information

- 1) Trade/Proprietary Name : Pobling MIITY 2
- 2) Common Name : Facial Toning Device
- 3) Classification Name : Transcutaneous Electrical Nerve Stimulator
- 4) Device Class : Class II
- 5) Product Code : NFO
- 6) Regulation Number : 21 CFR 882.5890

#### 3. Predicate Device

- 1) Carol Cole Company, NuFACE® Plus, K103472
- 2) Nu Skin Enterprises, Inc., NuSkin Facial Spa, K122711

#### 4. Intended Use

The Pobling MIITY 2 is intended for facial stimulation.

#### 5. Indication for Use

The Pobling MIITY 2 is indicated for over-the counter cosmetic use.

#### 6. Device Description

Pobling MIITY 2 is a facial toning device and it is composed of main unit and adaptor. The micro-current is delivered to healthy facial skin through head of main unit to stimulate the face. The device is a battery-powered and hand-held device. There have heating and cooling function by pressing the button additionally.

#### 7 Comparison with Predicate Device

The MITY 2 is identical with predicate devices for intended use and indications for use. It is

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Image /page/4/Picture/0 description: The image shows a stylized wordmark for "HABALAN" in a bold, sans-serif font. The letters are interconnected, creating a continuous, flowing design. The color of the text is black, and the background is white, providing a high contrast.

#### Different Insight

used as same technological principle with predicate devices to accomplish its intended use. all are hand-held, battery powered device and the there is no new questions of safety and/or effectiveness.

The determination of substantial equivalence for the MITY2 is based on an assessment of non-clinical performance. This assessment included a comparison of the MIITY2 to that of predicate. The output performance testing included:

- Maximum output voltaget
- Maximum output current

| Features | Subject Device | Predicate Device | | Justification |
|----------------------------------------|----------------------------------------------|--------------------|--------------------------------------------------------------------------------------------------------------------------|---------------|
| | MIITY 2 | NuFACE® Plus | NuSkin Facial Spa | — |
| 510(k) Number | To be assigned | K103472 | K122711 | — |
| Regulation Number | 21 CFR § 882.5890 | | | Same |
| Regulation Name | Transcutaneous Electrical Nerve Stimulator | | | Same |
| Regulatory Class | Class II | | | Same |
| Product Code | NFO | | | Same |
| Intended Use | Stimulate the face | | | Same |
| Indication for Use | Over-the-Counter Cosmetic Use | | | Same |
| Power Source | Battery operated | | | Same |
| Number output<br>channels | 1 | | | Same |
| Automatic shut off | Yes | | | Same |
| Indicator Display | | | | |
| 1) ON / OFF? | Yes | | | Same |
| 2) Low-Battery? | Yes | | | Same |
| On Time (seconds) | Constant | | | Same |
| Off Time (seconds) | None | | | Same |
| Compliance with<br>Voluntary Standards | IEC 60601-1 / IEC 60601-1-2 / IEC 60601-1-11 | | | Same |
| Mode | Two | One | One to Five | Similar |
| Wave form | Direct | Pulsed Monophasic | Direct Current | Same |
| Maximum Output<br>Voltage | @500Ω<br>Mode1: 174mV<br>Mode2: 174mV | @500Ω<br>137mV | @500Ω<br>Mode1: 188mV(214mV)<br>Mode2: 189mV(225mV)<br>Mode3: 185mV(220mV)<br>Mode4: 184mV(212mV)<br>Mode5: 184mV(213mV) | Similar |
| | @2kΩ<br>Mode1: 710mV<br>Mode2: 710mV | @2kΩ<br>769mV | @2kΩ<br>Mode1: 722mV(1527mV)<br>Mode2: 746mV(812mV)<br>Mode3: 735mV(815mV)<br>Mode4: 740mV(802mV)<br>Mode5: 741mV(801mV) | Similar |
| | Subject Device | Predicate Device | | Justification |
| Features | MIITY 2 | NuFACE® Plus | NuSkin Facial Spa | – |
| Maximum Output | @10kΩ | @10kΩ | @10kΩ | Similar |
| Voltage | Model: 3200mV | 3.82V | Model: 2.626V(2.978V) | |
| | Mode2: 3200mV | | Mode2: 3.787V(4.011V) | |
| | | | Mode3: 3.747V(4.014V) | |
| | | | Mode4: 3.503V(3.980V) | |
| | | | Mode5: 3.729V(3.980V) | |
| Maximum Output | @500Ω | @500Ω | @500Ω | Similar |
| Current | Model: 350uA | 274uA | Model: 376uA(427uA) | |
| | Mode2: 350uA | | Mode2: 379uA(449uA) | |
| | | | Mode3: 371uA(440uA) | |
| | | | Mode4: 368uA(424uA) | |
| | | | Mode5: 369uA(427uA) | |
| | @2kΩ | @2kΩ | @2kΩ | Similar |
| | Model: 360uA | 387uA | Model: 361uA(763uA) | |
| | Mode2: 360uA | | Mode2: 373uA(406uA) | |
| | | | Mode3: 367uA(407uA) | |
| | | | Mode4: 370uA(401uA) | |
| | | | Mode5: 370uA(400uA) | |
| | @10kΩ | @10kΩ | @10kΩ | Similar |
| | Model: 320uA | 383uA | Model: 362uA(398uA) | |
| | Mode2: 320uA | | Mode2: 379uA(401uA) | |
| | | | Mode3: 375uA(401uA) | |
| | | | Mode4: 350uA(398uA) | |
| | | | Mode5: 373uA(398uA) | |
| Heating and Cooling | Model: Heating | | | Minor |
| | (Temp. 41℃±3℃) | | | function |
| | Mode2: Cooling | | | |
| | (Temp. 10℃±3℃) | | | |
| Weight | 115g | 9oz | 120g (approx. 4oz) | – |
| | | | Facial Spa with Large | |
| Dimensions | 150 x 500<br>unit : mm | 3" x 5.25" x 1.25" | 143 x 31.2 x 67.5 mm | |
| | | | (5.6" x 1.2" x 2.7") | |
| | | | Facial Spa with Small | |
| | | | 136 x 31.2 x 67.5 mm | |
| | | | (5.4" x 1.2" x 2.7") | |
| Housing material | ABS | Thermo Plastic | ABS, Chrome plate | - |
| and construction | | | ABS, rubber (elastomer) | |

## TABLE : Comparison of MIITY 2 with predicate devices

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The heating and cooling are not a major function to be used as accomplished its intended use as stimulator. That are minor for distinguishing the mode. And also conducted the performance data. Therefore, all the difference don't affect the safety and effectiveness which is concluded after all the required testing, So no safety and effectiveness issues relating to the MIITY2

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Image /page/6/Picture/0 description: The image shows the logo for HABALAN. The logo is black and consists of the word "HABALAN" in a stylized font. Below the logo, the words "Different Insight" are written in a smaller, sans-serif font.

# 8. Performance Data

The following performance data were provided in support of the substantial equivalence determination 1) Electrical Safety and Electromagnetic compatibility(EMC)

Electrical safety and EMC testing were conducted on MITY2, it comples with the IEC 60601-1:2005 +am1:2002 for safety and the IEC 60601-1-2:2007 standard for EMC.

- 2) Biocompatibility Testing
The biocompatibility evaluation for the contact part with healthy facial skin of MIITY2 was conducted in accordance with the ISO 10993, Cytotoxicity, Skin Sensitization and Skin Irritation testing, it was considered contacting part and duration (Tissue contacting, Duration of less than 24hours)

- 4) Technical characteristic testing
To show the technical characteristic testing about Transcutaneous Electrical Nerve Stimulator, the test was conducted in our testing method.

- 5) Thermal Safety testing
The device have the heating and cooling function with stimulation. To verify the heating and cooling properties, we performed the testing in our testing method.

- 6) Clinical data
Not applicable

# 9. Conclusion

The fundamental technology to be accomplished its intended use in view of technological and operational characteristics between MITY2 and predicate device is same. Non-clinical performance as documented support the safety and effectiveness are similar to the predicate device. In other words, the MIITY2 is substantially equivalent to the predicate devices.