IPL Hair Removal Device

K213558 · Ulike Co., Ltd. · ONF · Mar 8, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K213558
• Device Name: IPL Hair Removal Device
• Applicant: Ulike Co., Ltd.
• Product Code: ONF · General, Plastic Surgery
• Decision Date: Mar 8, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IPL Hair Removal Device (Model: U104A, U104C) is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The IPL Hair Removal Device is also intended for permanent reduction in unwanted hair. Permanent hair reduction is 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 regimen.

Device Story

Portable IPL hair removal device; uses xenon lamp to emit pulsed light (550-1200nm) to heat hair roots via selective photothermal effect; features 5 energy levels (2-6J/cm²); includes skin proximity sensor to prevent pulse emission unless in full contact with skin; operated by patient under physician direction after professional training; intended for home use; output affects hair follicle growth to achieve long-term stable reduction; benefits patient through permanent hair reduction.

Clinical Evidence

Bench testing only. Device evaluated for electrical safety (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57) and biocompatibility (ISO 10993-5, ISO 10993-10). No clinical data provided.

Technological Characteristics

Portable IPL device; ABS housing; Xenon lamp energy source; 550-1200nm spectrum; 2-6J/cm² fluence; 0.54-3.00ms pulse width; 5 energy levels; skin proximity sensor; external power adapter; complies with IEC 60601-1, 60601-1-2, 60601-2-57.

Indications for Use

Indicated for patients seeking removal of unwanted hair and permanent hair reduction on body areas including underarms, bikini line, arms, and legs.

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

• Aimanfun Lumea Comfort (K190820)
• iPulse SmoothSkin Gold Hair Removal System (K160968)
• SHASER V-MINI RX (K132170)

Submission Summary (Full Text)

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March 8, 2022

Ulike Co., Ltd % Bryan Wong Associate, RAC PureVision Ai, Inc. 111 Town Square Place. Suite 1203 Jersey City, New Jersey 07310

Re: K213558

Trade/Device Name: IPL Hair Removal 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: ONF Dated: November 8, 2021 Received: November 8, 2021

Dear Bryan Wong:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K213558

Device Name IPL Hair Removal Device

#### Indications for Use (Describe)

The IPL Hair Removal Device (Model: U104A, U104C) is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The IPL Hair Removal Device is also intended for permanent reduction in unwanted hair.

Permanent hair reduction is 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 regimen.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

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

| Sponsor | |
|---------------------------|-------------------------------------------------------------|
| Company Name | Ulike Co., Ltd |
| Address | 2, Myeongdong, 6-gil, Jung-gu, Seoul, Korea |
| Contact Person | Ms. Lin Xiaoming |
| Title | Quality Manager |
| Email | [e-mail] |
| Application Correspondent | |
| Company Name | PUREVISION AI, INC. |
| Address | 111 Town Square Place, Ste 1203, Jersey City, New<br>Jersey |
| Contact Person | Mr. Bryan Wong |
| Title | Associate |
| Telephone | [phone] |
| Email | [e-mail] |

# 2. Subject Device Information

| Trade Name | IPL Hair Removal Device |
|---------------------|--------------------------------------------------------------------------|
| Classification Name | Powered Light Based Non-Laser Surgical Instrument<br>With Thermal Effect |
| Review Panel | General & Plastic Surgery |
| Product Code | ONF |

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Regulation Class 2

Requlation Number 878.4810

## 3. Predicate Device Information

Predicate device I - III:

| Predicate Device | I | II | III |
|----------------------|----------------------------------|-----------------------------------------------------|---------------------|
| Sponsor | Kam Yuen Plastic<br>Products Ltd | CyDen Limited | SHASER, INC. |
| Device Name | Aimanfun Lumea<br>Comfort | iPulse<br>SmoothSkin Gold<br>Hair Removal<br>System | SHASER V-MINI<br>RX |
| 510(k) Number | K190820 | K160968 | K132170 |
| Product Code | ONF | OHT | ONF |
| Regulation<br>Number | 878.4810 | 878.4810 | 878.4810 |
| Regulation Class | 2 | 2 | 2 |

### 4. Device Description

IPL Hair Removal Device, Model: UI04A, UI04B, UI04C, is a light-based device for long-term hair removal. It is intended for the removal of unwanted hair and permanent reduction in hair regrowth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the IPL technology with lower energy level, including 5 Levels of output energy. Intense Pulsed light technology can achieve long-term hair removal results at a fraction of the energy level used in other light -based hair removal equipment.

The size of the device is about 60*38*169.86mm (W x D x H). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.

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The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Removal Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.

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

The IPL Hair Removal Device (Model: U104A, U104C) is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The IPL Hair Removal Device is also intended for permanent reduction in unwanted hair.

#### 6. Design

IPL Hair Removal Device consists of main unit and adaptor. It is a portable device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL) which is a xenon lamp.

The size of the device is about 60*38*169.86mm (W x D x H). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.

The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Removal Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered to emit a pulse.

#### 7. Materials

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

| Component of<br>Device requiring<br>Biocompatibility | Material of<br>Component | Body Contact<br>Category (ISO<br>10993-1) | Contact Duration<br>(ISO 10993-1) |
|------------------------------------------------------|--------------------------|-------------------------------------------|-----------------------------------|
| Unit housing | ABS | Surface-contacting<br>device: skin | Maximum 30<br>minutes(< 24 |

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| | | hours) |
|--|--|--------|
| | | |

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

| Basic Unit Characteristics | |
|-------------------------------------|-----------------------------------------------------------------------------------|
| Main Unit Dimension | 60*38*169.86mm |
| Unit housing material | ABS |
| Indicator | Indicates power information/skin detection information, energy level information. |
| Environment for operation | Temperature: 15-30°C<br>Humidity: 10%-90% |
| Storage and Transport Conditions | Temperature: -10-60°C<br>Humidity: 5%-90% |
| Compliance with Voluntary Standards | Yes. Comply with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57. |
| Patient leakage current | Comply with IEC 60601-1 |
| Power Source | Supplied by external adapter |
| Software/Firmware/Microprocessor | Yes |
| Control? | |
| Specification | |

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| Output Intensity Level | 5 levels |
|------------------------|----------------|
| Output energy | 2-6J/cm² |
| Emitted Light Spectrum | 550-1200nm |
| Pulse width range | 0.54-3.00ms |
| Power Supply | External power |
| Technology | IPL |

### 9. Test Summary

IPL Hair Removal Device, Model: UI04A has been evaluated the safety and performance by lab bench testing as following:

IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2012 +A1:2012

IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, 2014

IEC 60601-1-11:2015 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 60601-2-57:2011 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

ISO 10993-5:2009/(R) 2014, Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.

ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

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Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff

#### 10. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, and intended use of IPL Hair Removal Device, model: UI04A, UI04C is substantially equivalent to the predicate devices quoted above.

IPL Hair Removal Device relies on the same technology as both predicate devices: Intense Pulsed Light (IPL). Their energy source is the same: Xenon Arc Flashlamp.

The safety and efficacy of IPL treatment for hair reduction are governed by the following parameters:

· Wavelength of the emitted light (spectrum): Defines the interaction with specific chromophores (the part of the molecule responsible for its color) such as melanin, hemoglobin and water. IPL Hair Removal Device and the predicate devices utilize the same spectrum(550-1200nm).

• Fluence/flux – defines the energy per area (e.g. joules per cm²) for the treatment. IPL Hair Removal Device and the predicate devices deliver the same maximum energy (6 J/cm2).

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

#### Conclusion:

The subject device "IPL Hair Removal Device, Model: UI04A, UI04B, UI04C" is substantial equivalent to all predicate devices.