IPL Hair Removal, Model: W-1095, W-1098

K232124 · Shenzhen Wochuan Electronic Co., Ltd. · OHT · Sep 14, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K232124
• Device Name: IPL Hair Removal, Model: W-1095, W-1098
• Applicant: Shenzhen Wochuan Electronic Co., Ltd.
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Sep 14, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

IPL Hair Removal is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Device Story

Personal, light-based hair reduction device; uses Intense Pulsed Light (IPL) technology via Xenon lamp to reduce hair growth; intended for OTC use by consumers on body and facial hair. Device powered by external adapter; operation triggered by finger switch. Includes skin sensor to ensure full contact with treatment area before pulse emission; prevents accidental firing. Device transforms electrical energy into light pulses; light energy absorbed by hair follicles below skin surface. Used in home environment; no cutting or pulling involved. Output parameters (energy density, pulse duration) vary by model (W-1095, W-1098). Benefits include hair reduction with minimal pain. Healthcare providers do not operate; user follows device instructions for treatment.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance verified via electrical safety (IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-83), photobiological safety (IEC 62471), and biocompatibility (ISO 10993-5, ISO 10993-10). Software verification/validation and usability evaluation performed per FDA guidance.

Technological Characteristics

Materials: ABS, PS. Energy source: External power adapter (100-240V AC, 12V 3A DC). Light source: Xenon arc flashlamp. Wavelength: 470-1100nm. Energy density: 1.16-4.46 J/cm². Spot size: 2.69-4.3 cm². Pulse duration: 4-13ms. Connectivity: None. Sterilization: Not required. Software: Microprocessor-controlled with skin contact sensor interlock.

Indications for Use

Indicated for removal of unwanted body and/or facial hair in adults with Fitzpatrick skin phototypes I-V.

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 HANDSET (K220669)
• IPL Home Use Hair Removal Device (K192432)

Reference Devices

• IPL Hair Removal, Model: OBT-02 (K213041)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services-USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

September 14, 2023

Shenzhen Wochuan Electronic Co., Ltd % Tracy Che Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Qianhai Road Shenzhen, Guangdong 518052 China

Re: K232124

Trade/Device Name: IPL Hair Removal, Model: W-1095, W-1098 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: July 12, 2023 Received: July 17, 2023

Dear Tracy Che:

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

{1}------------------------------------------------

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 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 | Digitally signed by<br>Jianting Wang -S |
|----------|-----------------------------------------|
| Wang -S | Date: 2023.09.14<br>16:11:07 -04'00' |

For Tanisha Hithe, MS. MHS 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K232124

Device Name IPL Hair Removal, Model: W-1095, W-1098

Indications for Use (Describe)

IPL Hair Removal is an over-the-counter device intended for removal of unwanted body and/or facial 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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510 (k) Summary K232124

This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.

# (1) Applicant information:

| 510(k) owner's name: | Shenzhen Wochuan Electronic Co., Ltd |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 6th Floor Building No.357 3rd Area A Huayuan Xingye 1 road,<br>Fenghuang Community, Fuyong Street, Baoan District, Shenzhen,<br>Guangdong China |
| Contact person: | Rebecca Jiang |
| Phone number: | [phone] |
| Fax number: | / |
| Email: | [e-mail] |
| Date of summary prepared: | 2023-07-12 |

# (2) Reason for the submission

New device, there were no prior submissions for the device.

# (3) Proprietary name of the device

| Trade name/model: | IPL Hair Removal, Model: W-1095, W-1098 |
|--------------------|-------------------------------------------|
| Common name: | Light Based Over-The-Counter Hair Removal |
| Regulation number: | 21 CFR 878.4810 |
| Product code: | OHT |
| Review panel: | General & Plastic Surgery |
| Regulation class: | Class II |

# (4) Predicate and reference devices

#### Predicate devices A

| | Primary predicate device | Predicate device |
|-----------------------|-------------------------------------------------|--------------------------------------------------------------------------------------------|
| Sponsor | Shenzhen<br>Junbobeauty<br>Technology Co., Ltd. | Shenzhen Bosidin Technology<br>Co.,Ltd. |
| Device Name and Model | IPL HAIR REMOVAL<br>HANDSET<br>Model: IPL-666 | IPL Home Use Hair Removal<br>Device<br>Model(s): D-1128, D-1103,<br>D-1119, D-1129, D-1130 |
| 510(k) Number | K220669 | K192432 |
| Product Code | OHT | OHT |

{4}------------------------------------------------

| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 |
|-------------------|-----------------|-----------------|
| Regulation Class | II | II |

#### > Reference device

| Sponsor | Glan Electronics Co., Ltd. |
|-----------------------|---------------------------------|
| Device Name and Model | IPL Hair Removal, Model: OBT-02 |
| 510(k) Number | K213041 |
| Product Code | OHT |
| Regulation Number | 21 CFR 878.4810 |
| Regulation Class | II |

# (5) Description/ Design of device:

The IPL Hair Removal 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 Intense Pulsed Light (IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains Xenon Lamp to emit light and skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot trigger a pulse. The IPL Hair Removal includes two models, W-1095 and W-1098. The two models are the same in intended use, working principle, the main differences are appearance and output parameters.

# (6) Indications for use:

IPL Hair Removal is an over-the-counter device intended for removal of unwanted body and/or facial hair.

| Component<br>name | Material of Component | Body Contact Category | Contact Duration |
|-------------------------------------|-----------------------|-------------------------------------------|--------------------|
| IPL Hair Removal<br>(Model: W-1095) | ABS+PS | Surface-contacting<br>device: Intact skin | Less than 24 hours |
| IPL Hair Removal<br>(Model: W-1098) | ABS | Surface-contacting<br>device: Intact skin | Less than 24 hours |

# (7) Materials

We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to "Biocompatibility Discussion".

# (8) Technological characteristics and substantial equivalence:

{5}------------------------------------------------

| Item | Subject device | Primary predicate<br>device | Predicate device | Reference device | Remark |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Trade name | IPL Hair Removal,<br>Model W-1095,<br>W-1098 | IPL HAIR REMOVAL<br>HANDSET<br>Model: IPL-666 | IPL Home Use Hair<br>Removal Device<br>Model(s): D-1128,<br>D-1103, D-1119,<br>D-1129, D-1130 | IPL Hair Removal,<br>Model: OBT-02 | / |
| 510 (k)<br>number | Applying | K220669 | K192432 | K213041 | / |
| Manufacturer | Shenzhen Wochuan<br>Electronic Co., Ltd | Shenzhen Junbobeauty<br>Technology Co., Ltd. | Shenzhen Bosidin<br>Technology Co., Ltd. | Glan Electronics<br>Co., Ltd. | / |
| Regulation<br>number | 21CFR 878.4810 | 21CFR 878.4810 | 21CFR 878.4810 | 21CFR 878.4810 | Same |
| Product code | OHT | OHT | OHT | OHT | Same |
| Class | II | II | II | II | Same |
| Indications<br>for<br>use/<br>Intended use | IPL Hair Removal is<br>an over-the-counter<br>device intended<br>for<br>removal of unwanted<br>body<br>and/or<br>facial<br>hair. | IPL HAIR REMOVAL<br>HANDSET is an over-<br>the-counter<br>device<br>intended for removal of<br>unwanted body and/or<br>facial hair. | IPL Home Use Hair<br>Removal Device is an<br>over-the-counter<br>device intended<br>for<br>removal of unwanted<br>body and/or facial hair. | The IPL Hair<br>Removal Device<br>OBT-02 Version<br>is indicated for the<br>removal of<br>unwanted hair. The<br>device is also<br>indicated for the<br>permanent<br>reduction in hair<br>regrowth, defined<br>as the long-term,<br>stable reduction in<br>the number of hairs<br>re-growing when<br>measured at 6, 9<br>and 12 months<br>after the<br>completion of a<br>treatment regime.<br>The device is used<br>for adults. | Same |
| Prescription<br>or OTC | OTC | OTC | OTC | OTC | Same |
| Applicable | Fitzpatrick<br>Skin | Fitzpatrick<br>Skin | Fitzpatrick<br>Skin | Unknown | Same |
| skin | Phototypes I-V | Phototypes I-V | Phototypes I-V | | Similar |
| Treatment<br>area | Multiple hair removal<br>areas, including small<br>areas (e.g. armpit,<br>bikini lines) and large<br>areas (e.g. arms, legs). | The device is designed<br>for use on the legs,<br>underarms,<br>bikini line, chest,<br>stomach, back, arms<br>and on the face below<br>the cheekbones. | Removal of unwanted<br>body hair such as but<br>not limited to small<br>areas such as underarm<br>and facial hair below<br>the chin line and large<br>areas such as legs. | Unknown | |
| Device design | | | | | |
| Power source | An external power<br>supply | An external power<br>supply | Supplied by external<br>power adapter | Supplied by<br>external adapter | Same |
| Power supply | 100~240V AC Input<br>DC 12V 3A Output | 100~240V AC Input<br>12V3A DC Output | Input:<br>100-240V<br>50/60Hz 1.0-0.5A<br>Output: DC12V 3A | 100-240 V AC | Same |
| Product<br>compositions | IPL Hair Removal<br>main device and<br>power adapter | IPL Hair Removal<br>Handset and power<br>adapter | IPL host, lamp<br>cartridge and power<br>adapter | IPL device and<br>power supply | Similar |
| Structure<br>design | Handheld | Handheld | Handheld | Handheld | Same |
| Dimension | W-1095:163*60*37mm<br>W-1098:170.5*68.5*43mm | 124*83*48.5mm | 218 x 144 x 60mm | 150*75*45mm<br>(H*W*D) | Different |
| Weight | W-1095:~223.5g<br>W-1098:256.92g | 186g | 355g | 220g | Different |
| Sterilization | Not required | Not required | Not required | Not required | Same |
| Output specification | | | | | |
| Light source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed<br>Light | Same |
| Energy<br>medium | Xenon Arc flashlamp | Xenon Quartz Tube | Xenon lamp | Xenon Arc<br>Flashlamp | Same |
| Wavelength<br>range (nm) | 470nm ~1100nm | 470nm ~1100nm | Regular window: 510<br>~ 1100nm<br>Filter window: 600 ~<br>1100mm | 510nm~1100nm | Same |
| Energy<br>density<br>(J/cm²) | W-1095:1.67~4.46J/cm²<br>W-1098:1.16~2.79J/cm² | 1.3-2.49J/cm² | 2.0~4.0J/cm²<br>(applicable for<br>model D-1128,<br>D-1119, D-1129,<br>D-1130)<br>2.5~4.5J/cm²<br>(Applicable for model<br>D-1103) | 1.5-4.0J/cm2 | Similar |
| Spot<br>size | W-1095: 2.69cm² | 3cm² | Regular window: | 3.0cm² | Similar |
| (Size of<br>treatment<br>window)<br>(cm²) | W-1098: 4.3cm² | | $4.5cm^2$ , $2.0cm^2$ ,<br>$3.0cm^2$<br>Filter window: 2.5cm² | | |
| Pulse<br>duration | 4-13ms | 11.5-15ms | 7.5-14ms | 3ms | Similar |
| Pulsing<br>control | Finger switch | Finger switch | Finger switch | Finger switch | Same |
| Delivery<br>device | Direct illumination to<br>tissue | Direct illumination to<br>tissue | Direct illumination to<br>tissue | Direct illumination<br>to tissue | Same |
| Number of<br>output<br>channels | One channel | One channel | One channel | One channel | Same |
| Output<br>intensity<br>level | W-1095: 5 levels<br>W-1098: 3 levels | 5 levels | 5 levels | 5 levels | Similar |
| Skin sensor | Sensor fixed in device<br>and can be moved to<br>treatment part | Sensor fixed in handset<br>and can be moved to<br>treatment part | Sensor fixed in device<br>and can be moved to<br>treatment part | Sensor fixed in<br>device and can be<br>moved to treatment<br>part | Same |
| Software/<br>Firmware/<br>Microprocess<br>or<br>Control? | Yes | Yes | Yes | Yes | Same |
| Additional features | | | | | |
| Skin-<br>contacting<br>components | Enclosure and light<br>outlet | Plastic enclosure and<br>treatment window | Plastic enclosure and<br>treatment window | Enclosure and<br>treatment window | Same |
| Materials of<br>skin-<br>contacting<br>components | ABS, PS | Plastic, metal | ABS, PC, Aluminium<br>alloy | Unknown | Different |
| Biocompatibi<br>lity | All user directly<br>contacting materials<br>are compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements. | All user directly<br>contacting materials<br>are compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements. | All user directly<br>contacting materials<br>are compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements. | All user directly<br>contacting<br>materials are<br>compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements. | Same |
| Electrical<br>safety | IEC60601-1-2<br>IEC60601-1<br>IEC60601-1-11<br>IEC60601-2-83 | IEC60601-1-2<br>IEC60601-1<br>IEC60601-1-11<br>IEC60601-2-83 | IEC60601-1-2<br>IEC60601-1<br>IEC60601-1-11<br>IEC60601-2-57 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-2-57 | Same |
| Photobiological safety | IEC62471 | IEC62471 | IEC62471 | Unknown | Same |

{6}------------------------------------------------

Shenzhen Wochuan Electronic Co., Ltd
510(k)s – Section 8. 510 (k) Summary

{7}------------------------------------------------

{8}------------------------------------------------

# (9) Non-clinical studies and tests performed:

Non-clinical testings have been conducted to verify that the IPL Hair Removal meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate devices. The testing results demonstrate that the subject device complies with the following standards:

- A IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- > IEC 60601-1-11, Medical electrical equipment - Part 1-11: 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 60601-2-83, Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
- > IEC 62471, Photobiological safety of lamps and lamp systems

The device has been tested for biocompatibility, it complies with the following standards.

- A ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for InVitro Cytotoxicity
- A ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.

We have also conducted:

- A Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- A Usability evaluation according to the requirements of the FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016"

# (10) Conclusion

Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device IPL Hair Removal is as safe, as effective, and performs as well as the legally marketed predicate devices and reference device.