IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S

K231215 · Zhongshan Qizhe Technology Co., Ltd. · OHT · Jun 26, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K231215
• Device Name: IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S
• Applicant: Zhongshan Qizhe Technology Co., Ltd.
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Jun 26, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IPL Hair Removal device (Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S) is an Over the Counter device intended for the removal of unwanted body hair.

Device Story

Hand-held IPL device for home-use hair removal; utilizes Xenon arc flashlamp to emit light (510-1100nm) absorbed by hair melanin; converts light to heat to disable hair follicles. Features capacitive skin contact sensor and skin color sensor to prevent operation on unsuitable skin tones. Includes cooling care mode for thermal comfort. Powered by rechargeable lithium battery or external AC adapter. Operated by patient; device requires full skin contact for pulse emission. Output energy 12-18J; spot size 3.1cm². Benefits include reduction of hair growth without cutting or pulling.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (ANSI AAMI ES60601-1), EMC (IEC 60601-1-2), photobiological safety (IEC 62471), and biocompatibility (ISO 10993-5, ISO 10993-10).

Technological Characteristics

Hand-held IPL device; Xenon arc flashlamp; 510-1100nm wavelength; 3.1cm² spot size; 3.8-5.5 J/cm² fluence. Materials: ABS (housing/buttons), PC (probe/window), sapphire crystal (cooling). Power: rechargeable Li-ion battery or external adapter. Connectivity: none. Software: IEC 62304 compliant. Sterilization: N/A.

Indications for Use

Indicated for removal of unwanted body hair in adults aged over 18.

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

• IPL Hair Removal Device (K183217)
• IPL Hair Removal Device (K223928)

Submission Summary (Full Text)

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June 26, 2023

ZhongShan Qizhe Technology Co., Ltd. % You Yijie Manager Qimmiq Medical Consulting Service Co., Ltd. RM.406, Building C, Run Science Park, No.18 Shenzhou Road, Huangpu Guangdong, Guangdong 510663 China

Re: K231215

Trade/Device Name: IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S 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: April 20, 2023 Received: April 28, 2023

Dear You Yijie:

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 medical devices and radiation-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,

Jianting Wang -S

Jianting Wang Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known)

K231215

Device Name

IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL008S

Indications for Use (Describe)

The IPL Hair Removal device (Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S) is an Over the Counter device intended for the removal of unwanted body hair.

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

# K231215

## 1. Submitters Information

### Establishment Registration Information

| Name: | Zhongshan Qizhe Technology Co., Ltd |
|----------|-------------------------------------------------------------------------------------------------------------|
| Address: | 23 Tongji West Road, Nantou Town, Zhongshan City<br>(Room 902, Building 8, Hongji Industrial City Phase II) |

Contact Person of applicant:

| Name: | Gan Guiping |
|----------|-----------------------------------------------------------------------------------------------------------|
| Address: | 23 Tongji West Road,Nantou Town,Zhongshan City<br>(Room 902, Building 8, Hongji Industrial City Phase II) |
| TEL: | [phone] |
| Email: | [e-mail] |

Contact Person of the Submission:

| Name: | You Yijie |
|----------|------------------------------------------------------------------------------------------------------------------|
| Address: | RM.406, Building C, Run Science Park, No.18<br>Shenzhou Road, Huangpu, Guangzhou, Guangdong<br>510663 P.R. China |
| TEL: | ([phone] |
| FAX: | ([phone] |
| Email: | [e-mail] |

Date of the summary prepared: Jun. 15, 2023

#### 2. Device Information

| Trade Name: | IPL Hair Removal device |
|-----------------------|--------------------------------------------------------------------------|
| Model: | Skin Expert Pro IPL 008<br>Skin Expert Pro IPL 008S |
| Classification name: | Light Based Over-The-Counter Hair Removal |
| Common or Usual Name: | Powered Light Based Non-Laser Surgical Instrument With<br>Thermal Effect |
| Review panel: | General&Plastic Surgery |
| Product code: | OHT |
| Regulation Class: | II |
| Regulation Number: | 878.4810 |

### 3. Predicate Device Information

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#### Primary Predicate Device 1

| 510(k) submitter/holder: | Touchbeauty Beauty & Health<br>(Shenzhen) Co., Ltd |
|--------------------------|----------------------------------------------------|
| 510(K) Number: | K183217 |
| Trade Name | IPL Hair Removal Device |
| Model | TB-1755 |
| Classification name | Light Based Over-The-Counter Hair<br>Removal |
| Review panel | General & Plastic Surgery |
| Product code | OHT, ONF |
| Regulation Class | II |
| Regulation Number | 878.4810 |

#### Primary Predicate Device 2

| 510(k) submitter/holder: | Shenzhen Fansizhe Science and<br>Technology Co., Ltd |
|--------------------------|-------------------------------------------------------------------------------------------|
| 510(K) Number: | K223928 |
| Trade Name | IPL Hair Removal Device |
| Model | T016K |
| Classification name | Laser Surgical Instrument For Use In<br>General And Plastic Surgery And In<br>Dermatology |
| Review panel | General & Plastic Surgery |
| Product code | OHT |
| Regulation Class | II |
| Regulation Number | 878.4810 |

## 4. Device description

IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S are a small over-the-counter device for the reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is powered by the external power adaptor or built-in battery and its IPL emission activation is by a switch or auto light emission.

IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S, contains a Xenon arc flashlamp, one built-in battery, a capacitive sensor to detect appropriate skin contact, and a skin color sensor to detect the skin color sensor is fixed in "Skin color recognition Window" of IPL Hair Removal device, and the device's skin color sensor automatically detects skin tone for your protection when the device is powered on. If your skin tone is not in tone table suitable for treatment, the device must not be used. You need to identify your skin tone before treatment according to skin tone table, and confirm whether the product is applicable to you after the skin color sensor detects a skin tone. The capacitive sensor is assembled in the device probe of IPL Hair Removal device, if the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses.

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Based on the cooling technology, IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S, has cooling care functions. When the cooling care mode is enabled, it can reduce the excessive heat generated on the skin by the photon irradiation and do cooling compresses during hair removal.

The IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S can be powered on built-in battery or cable adaptor. The built-in lithium battery can be recharged. When the capacity of battery is low, the battery icon " " " display red on the screen. When the When battery icon " t = " display red with blinking for about 20s the device will turn off. The recharge time of the battery is about 3 hours and when full charged and turn on level 5 to treatment the using time about 45 mins.

When the device is turned on under battery-powered and insert the adaptor with the device, the device will be shut down and to charge. If you want to treatment, you shall turn on the device again with the cable adaptor.

When device is turned on under cable adaptor, then take off the adaptor, the device will be shut down. If you still want to treatment, you shall turn on the device again.

The IPL Hair Removal Device includes main unit (including built-in battery), an adaptor, goggles and shaver.

The device is intended to be used for adults aged over 18.

#### Principle of operation:

Hair has a growth cycle, which can be roughly divided into incubation period, growth period and decline period. The growth period hair has a complete structure such as hair follicles and hair shafts. The hair in the incubation period and the decline period does not have the hair follicle structure. The removal of excess hair is to take advantage of the characteristics of the anatomical structure of hair. The device based on the IPL technology emits a specific wavelength of the light and delivers the light to the skin. It is designed to help break the cycle of hair re-growth. Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair shaft. The absorbed light energy is converted to heat energy below the surface of the skin, which disables the hair follicle preventing further growth. Therefore, the device achieves effective hair removal.

## 5. Indications for Use

IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S is an Overthe Counter device intended for the removal of unwanted body hair.

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## 6. Summary of technological characteristics of device compared to the predicate device1 (K183217) and

## predicate device2(K160968)

| SE<br>Comparisons | Subject device<br>(IPL Hair Removal device,<br>model: Skin Expert Pro IPL 008,<br>Skin Expert Pro IPL 008S) | Predicate device 1<br>(IPL Hair Removal Device, Model:<br>TB-1755) | Predicate device 2<br>(IPL Hair Removal Device, Model:<br>T016K) | Discussion of<br>difference |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| 510K Number | / | K183217 | K223928 | / |
| Classification | 21CFR 878.4810 | 21CFR 878.4810 | 21CFR 878.4810 | Same |
| Product Code | OHT | OHT, ONF | OHT | Same |
| FDA Class | II | II | II | Same |
| Indications for Use | The IPL Hair Removal device(model:<br>Skin Expert Pro IPL 008, Skin Expert<br>Pro IPL 008S) is an Over the Counter<br>device intended for the removal of<br>unwanted body hair. | The IPL Hair Removal device (model:<br>TB-1755) is an Over the Counter<br>device intended for the removal of<br>unwanted body hair. | The IPL Hair Removal Device is an<br>over-the-counter device intended for<br>the removal of unwanted body hair. | Same |
| Environment of Use | Home use | Home use | Home use | Same |
| Design | Hand-hold | Hand-hold | Hand-hold | Same |
| Patient Population | Adult | Adult | Adult | Same |
| Material of Patient<br>contact components | ABS for button, ABS for main housing,<br>PC for Probe cover, PC for Light Exit<br>Window, PC for Touch key-press ,<br>Sapphire Crystal Cooling Compress | Not public | PC for button, PC for main housing<br>and Probe cover, Sapphire Crystal<br>Cooling Compress | Different<br>(Discussion is<br>indicated in D1) |
| Biocompability testing | 1.Type of contact: direct contact for<br>users and patients.<br>2.Nature of body contact category:<br>Surface Contact class: A (<24 h)<br>3.Meets ISO 10993- 5, ISO 10993-10 | Not public | 1.Type of contact: direct contact for<br>users and patients.<br>2.Nature of body contact category:<br>Surface Contact class: A (<24 h)<br>3.Meets ISO 10993- 5, ISO 10993-10 | Same |
| Single Patient,<br>multi-use | Yes | Yes | Yes | Same |
| Patient Interface | Buttons | Buttons | Buttons | Same |
| Technology | Intense Pulse Light (IPL) | Intense Pulse Light (IPL) | Intense Pulse Light (IPL) | Same |
| SE<br>Comparisons | Subject device<br>(IPL Hair Removal device,<br>model: Skin Expert Pro IPL 008,<br>Skin Expert Pro IPL 008S) | Predicate device 1<br>(IPL Hair Removal Device, Model:<br>TB-1755) | Predicate device 2<br>(IPL Hair Removal Device, Model:<br>T016K) | Discussion of<br>difference |
| Dimensions | 153*185*52mm for Skin Expert Pro IPL<br>008S<br>140*191*54mm for Skin Expert Pro IPL<br>008S | 182*72.4*69.2mm | 90*44*225mm | Different<br>(Discussion is<br>indicated in D2) |
| Power source | An external power supply and built-in<br>battery | An external power supply | An external power supply | Different<br>(Discussion is<br>indicated in D3) |
| Light source | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Same |
| Wavelength | 510nm~1100nm | 510-1100nm | 510nm~1200nm | Different<br>(Discussion is<br>indicated in D4) |
| Spot Size | 3.1cm² | 3.1 cm² | 3.3cm² | Different<br>(Discussion is<br>indicated in D5) |
| Max. Fluence (J/cm²) | 3.8-5.5 J/cm² | 3.8-5.2 J/cm² | 1.45-5.73J/cm² | Different<br>(Discussion is<br>indicated in D6) |
| Pulse duration | 3ms -9ms | 3ms | 4ms-12ms | Different<br>(Discussion is<br>indicated in D7) |
| Output energy | 12J -18J | 12J-16J | 4.8J~18.9J | Different<br>(Discussion is<br>indicated in D8) |
| Pulsing<br>Control | Finger switch | Finger switch | Finger switch | Same |
| Output<br>Channel | One channel | One channel | One channel | Same |
| Delivery | Direct Illumination to Tissue | Direct Illumination to Tissue | Direct Illumination to Tissue | Same |
| Software<br>Control | Yes | Yes | Yes | Same |
| Electrical<br>safety, EMC,<br>Biological<br>Evaluation | ANSI AAMI ES60601-1<br>IEC 60601-1-2<br>ANSI/AAMI HA60601-1-11<br>IEC 60601-2-83<br>IEC 62471 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-2-57<br>IEC 62471 | ANSI AAMI ES60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-2-83<br>IEC 62471 | Different<br>(Discussion is<br>indicated in D9) |
| SE<br>Comparisons | Subject device<br>(IPL Hair Removal device,<br>model: Skin Expert Pro IPL 008,<br>Skin Expert Pro IPL 008S) | Predicate device 1<br>(IPL Hair Removal Device, Model:<br>TB-1755) | Predicate device 2<br>(IPL Hair Removal Device, Model:<br>T016K) | Discussion of<br>difference |
| | ISO 10993-5<br>ISO 10993-10<br>IEC 62133-2 | ISO 10993-5<br>ISO 10993-10 | ISO 10993-5<br>ISO 10993-10 | |

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#### The discussion of differences exist between the subject and predicate devices is listed in following:

- D1: The subject device has been validated for cytotoxicy per ISO 1093-5 and Irritation as well as Sensitization per ISO 10993-10 with positive results, therefore, the material difference of subject device with Predicate device 2 (K223928, Model: T016K) do not raise new questions of safety and effectiveness.
- D2: The difference of dimensions will not affect the safety and effectiveness.
- D3: The subject device has demonstrated electrical safety by ANSI AAM ES6061 1 and ANSI AAM IEC 60601-1-2 testing. Therefore, the difference does not raise the issue of product's safety and effectiveness.
- D4: Wavelength of subject device is same with predicate device 2. The sately and effectiveness of the subject device is verified wa tests according to ANSI AAM ES60601-1-2, ANSIAAM H460601-1-11, IEC 62471 and IEC 60601-2-3, so the differences do not affect the safety and effectiveness.
- D5. Spot Size of subject device is same with predicate device 2. The safety and effectiveness of the subject device is verified via tests according to ANSI AAM ES60601-1, IEC60601-1-11, IEC 62471 and IEC 60601-2-83, so the differences do not affect the safety and effectiveness.
- D6: Max. Fluence of subject device is similar or within devices. The lower linit value of subject device is the same with predicate device 1, the range of subject device is covered by predicate device 2. The subject device is verified via tests according to ANSI AAM ES6001-1, IEC60601-1-2, ANSI/AAM HA60601-1-11, IEC 62471 and IEC 60601-2-83, so the differences do not affectiveness.
- DT: Pulse duration of subject devices. The lower limit value of subject device is the same with predicate device 1, and the Pulse duration of subject device is similar with the range of predice 2. The safety and effectiveness of the subject device is verified wa tests according to ANSI AAM ES60601-1, IEC60601-1-2, ANSIAAM HA60601-1-11, IEC 62471 and IEC 60601-2-83, so the differences do not affectiveness.
- D8: Output energy of subject device', and the range of subject device is covered by pedicate device 2. The safety and effectiveness of the subject device is verified via tests acording to ANSI AAM ES6061-1-2, ANSIAAMI HA60601-1-11, IEC 62471 and IEC 6001-2-83, so the differences do not affect the safety and effectiveness.

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D9: One of IEC 60601-2-83 and IEC 60601-2-57 is applicable for IPL Hair Removal device, so the diffect the safety and effectiveness. The IEC 62133-2 is applicable for the builtin Lithium battery, and subject device is verified via tests according to ANSI AAM ES60601-1, INS/AAM HA60601-1-11, IEC 62471 and IEC 60601-2-83, so the difference does not affect the safety and effectiveness.

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## 7. Discussion of Non-Clinical Tests Performed for Safety and

#### effectiveness are as follows

The recognized consensus standards for safety of medical electrical equipment: ANSI AAMI ES60601-1, ANSI/AAMI HA60601-1-11, IEC 62133-2 for safety, IEC 60601-1-2 for electromagnetic compatibility, IEC 60601-2-83:2011 for performance and IEC 62304 for software verification are complied. See below table for details:

| Standards | Standards Name |
|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ANSI AAMIES60601-<br>1:2005/(R)2012 A1:2012,<br>C1:2009/(R)2012<br>A2:2010/(R)2012 (Cons. Text)<br>[Incl. AMD2:2021] | Medical Electrical Equipment - Part 1: General Requirements<br>For Basic Safety And Essential Performance |
| IEC 60601-1-2: 2014 | Medical Electrical Equipment -- Part 1-2: General Requirements<br>For Basic Safety And Essential Performance -- Collateral<br>Standard: Electromagnetic Disturbances -- Requirements And<br>Tests |
| ANSI/AAMI HA60601-1-<br>11:2015 + A1:2021 | Medical Electrical Equipment - Part 1-2: General Requirements<br>For Basic Safety And Essential Performance - Collateral<br>Standard: Electromagnetic Disturbances - Requirements And<br>Tests |
| IEC 60601-2-83:2019 | Medical electrical equipment Part 2-83: Particular requirements<br>for the basic safety and essential performance of home light<br>therapy equipment |
| IEC 62471: 2006 | Photobiological safety of lamps and lamp systems |
| ISO 10993-5 Third edition<br>2009-06-01 | Biological evaluation of medical devices - Part 5: Tests for in<br>vitro cytotoxicity |
| ISO 10993-10 Third Edition<br>2010-08-01 | Biological evaluation of medical devices - Part 10: Tests for<br>irritation and skin sensitization |
| IEC 62133-2 Edition1.0 2017-<br>02 | Secondary cells and batteries containing alkaline or other non-<br>acid electrolytes - Safety requirements for portable sealed<br>secondary cells, and for batteries made from them, for use in<br>portable applications - Part 2: Lithium systems |
| IEC 62304 Edition 1.1 2015-06<br>CONSOLIDATED VERSION | Medical device software - Software life cycle processes |

Software verification and validation was performed for the subject device in accordance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices -Guidance for Industry and FDA Staff, May 2005.

### 8. Discussion of Clinical Accuracy Testing Performed

There was no clinical testing performed.

### 9. Conclusions

Based on performance testing, comparison and analysis, the subject device IPL Hair Removal device,

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model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S, is substantially equivalent to the predicate devices.