IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG

K230122 · Shenzhen Ulike Smart Electronics Co., Ltd. · OHT · Apr 10, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K230122
• Device Name: IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG
• Applicant: Shenzhen Ulike Smart Electronics Co., Ltd.
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Apr 10, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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 regime.

Device Story

IPL Hair Removal Device (models UI04 SD, UI04 DG) is an over-the-counter, home-use device for hair reduction. Device uses Intense Pulsed Light (IPL) generated by a Xenon arc flashlamp to target hair follicles below the skin surface. User operates device via finger switch; skin sensor ensures device only emits pulses when in full contact with skin. Integrated cooling function operates during treatment to enhance user comfort. Device powered by external adapter. Output parameters include 560-1200nm wavelength, 2.4-7.2J/cm2 energy density, and 3.3cm2 spot size. Device provides non-invasive hair removal; intended to reduce hair regrowth over time. Healthcare providers do not operate device; it is for patient self-use. Output is light pulse delivery; clinical benefit is long-term hair reduction.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence includes biocompatibility (ISO 10993-5, ISO 10993-10), electrical safety/EMC (ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC 60601-2-83), photobiological eye safety (IEC 62471), and usability engineering (IEC 60601-1-6).

Technological Characteristics

Materials: ABS, PC, Crystal application. Energy: Xenon arc flashlamp (IPL). Output: 560-1200nm, 2.4-7.2J/cm2, 3.3cm2 spot size. Connectivity: Standalone, external power adapter. Safety: Skin contact sensor, integrated cooling. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC 60601-2-83, IEC 62471, ISO 10993-5/10.

Indications for Use

Indicated for removal of unwanted hair and permanent reduction in hair regrowth in adults. Suitable for Fitzpatrick skin types 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

• iPulse SmoothSkin Gold Hair Removal System (K160968)
• IPL Hair Removal Device Joy Version, CB-027 (K173813)

Reference Devices

• IPL HAIR REMOVAL SG-8025 (K212318)

Submission Summary (Full Text)

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Shenzhen Ulike Smart Electronics Co., Ltd % Riley Chen 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: K230122

Trade/Device Name: IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG 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: January 15, 2023 Received: January 17, 2023

Dear Riley Chen:

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.

## Colin K. Chen -S

for

Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K230122

Device Name IPL Hair Removal Device Model(s): UI04 SD, UI04 DG

#### Indications for Use (Describe)

IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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 regime.

| 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

### "510(k) Summary" as required by 21 CFR Part 807.92.

#### I. Submitter

Shenzhen Ulike Smart Electronics Co.,Ltd.

No.8, Keyuan Road, Yuehai Sub-district, Nanshan District, Shenzhen, Guangdong, China Post code: 518000 Tel.: [phone]

Shane Xie Registration Director Tel: [phone] Email: [e-mail]

#### II. Device

Name of Device: IPL Hair Removal Device Model(s): UI04 SD, UI04 DG Common or Usual Name: Light Based Over-The-Counter Hair Removal Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: OHT Regulation Number: 21 CFR 878.4810

#### III. Predicate Device

Primary predicate device:

| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
|----------------|-----------------------------------------------|---------------|---------------|
| CyDen Limited. | iPulse SmoothSkin Gold<br>Hair Removal System | K160968 | Apr.14, 2016 |

Predicate device:

| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|------------------------------|------------------------------------------------|---------------|----------------|
| Shen Zhen CosBeauty Co., Ltd | IPL Hair Removal Device<br>Joy Version, CB-027 | K173813 | Sept. 07, 2018 |

#### Reference device:

| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|------------------------------------------------------------|------------------------------|---------------|---------------|
| Dongguan Define Beauty<br>Electronic Technology Co.<br>Ltd | IPL HAIR REMOVAL SG-<br>8025 | K212318 | Jan.14, 2022 |

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#### IV. Device Description

IPL Hair Removal Device (Model: UI04 SD, UI04 DG), is an over-the-counter, home-use and personal device for hair reduction by using 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 only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts irreplaceable treatment window and the spot size is 3.3cm² that is suitable for multiple hair removal areas. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

IPL Hair Removal Device, model: UI04 SD, UI04 DG have the same indication for use, performance, structure design and operation, the only deference is their enclosure color (UI04 SD is Star White and UI04 DG is Dark Green).

#### V. Indications for Use

IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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 regime.

#### VI. Materials

| Component<br>name | Material of Component | Body Contact Category | Contact Duration |
|-------------------------------------------------------------------|---------------------------------|-------------------------------------------|--------------------|
| IPL Hair Removal<br>Device (Enclosure<br>and treatment<br>window) | ABS, PC,<br>Crystal application | Surface-contacting<br>device: Intact skin | Less than 24 hours |

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

#### VII.Comparison of Technological Characteristics With the Predicate Device

The IPL Hair Removal Device has the same intended use, mode of action and similar operational characteristics as the predicate device and reference devices. Any minor differences between the subject device and the listed predicate devices and reference device do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate devices and reference device for its intended use. Therefore, the IPL Hair Removal Device may be found substantially equivalent to its predicate devices and reference device.

IPL Hair Removal Device is compared with the following Predicate Devices and Reference Device in terms of intended use, design, specifications and performance:

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| Comparison<br>Elements | Subject Device | Primary Device | Predicate Device | Reference Device | Remark | |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------|
| 510(k)<br>Number | Pending | K160968 | K173813 | K212318 | / | |
| Trade name | IPL Hair Removal<br>Device | iPulse SmoothSkin<br>Gold Hair Removal<br>System | IPL Hair Removal<br>Device Joy Version, CB-<br>027 | IPL HAIR<br>REMOVAL SG-<br>8025 | / | |
| Manufacturer | Shenzhen Ulike<br>Smart Electronics<br>Co.,Ltd. | Cyden Limited. | Shen Zhen CosBeauty<br>Co., Ltd | Dongguan Define<br>Beauty Electronic<br>Technology Co.<br>Ltd | / | |
| Regulation<br>number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same | |
| Product code | OHT | OHT, GEX | OHT | OHT | Same | |
| Device<br>classification | Class II | Class II | Class II | Class II | Same | |
| Indication for<br>use/ Intended<br>use | IPL Hair Removal<br>Device is indicated<br>for the removal of<br>unwanted hair. The<br>device is also<br>indicated for the<br>permanent reduction<br>in hair regrowth,<br>defined as the long-<br>term, stable reduction<br>in the number of hairs<br>regrowing when<br>measured at 6, 9 and<br>12 months after the<br>completion of a<br>treatment regime. | The<br>iPulse SmoothSkin<br>Gold Hair Removal System<br>is indicated for the<br>removal of unwanted<br>hair. The iPulse<br>Smoothskin Gold is<br>also indicated for the<br>permanent reduction<br>in hair regrowth,<br>defined as the long-<br>term, stable reduction<br>in the number of hairs<br>regrowing when<br>measured at 6, 9 and<br>12 months after the<br>completion of a<br>treatment regime. | The IPL Hair Removal<br>Device Joy Version is<br>indicated for the<br>removal of unwanted<br>hair. The device is also<br>indicated for the<br>permanent reduction in<br>hair regrowth, defined<br>as the long-term, stable<br>reduction in the number<br>of hairs regrowing when<br>measured at 6, 9 and 12<br>months after the<br>completion of a<br>treatment regime. The<br>device is used for adults<br>with Fitzpatrick skin<br>types I - IV. | The IPL Hair<br>Removal (Model:<br>SG-8025) is an<br>over the Counter<br>device intended for<br>the removal of<br>unwanted body<br>and/or facial hair<br>in adults. It is also<br>intended for<br>permanent<br>reduction in<br>unwanted hair.<br>Permanent hair<br>reduction is<br>defined as the<br>long-term stable<br>reduction in the<br>number of hairs re-<br>growing when<br>measured at 6. 9.<br>and 12 months<br>after the<br>completion of a<br>treatment regimen. | Same,<br>only wording<br>difference | |
| Prescription<br>or OTC | OTC | OTC | OTC | OTC | Same | |
| Applicable | Fitzpatrick<br>Skin | Unknown | Fitzpatrick skin types I - | Unknown | Different | |
| Comparison<br>Elements | Subject Device | Primary Device | Predicate Device | Reference Device | Remark | |
| skin | Types I-V | | IV | | | |
| Treatment<br>area | large areas (e.g. arms,<br>legs, chest) and small<br>areas (e.g. lip) | Unknown | Large areas (legs, arms,<br>back and abdomen), face<br>(upper lip, chin and<br>sideburns) | Body and face | Similar | |
| Device design | | | | | | |
| Source<br>energy | Supplied by external<br>adapter | External Power<br>supply | Supplied by external<br>adapter | Supplied by<br>external adapter | Same | |
| Power supply | 100~240V, 50/60Hz | 110V or 230V,<br>50/60Hz | 100-240 VAC, 50/60Hz | Unknown | Same | |
| Dimension | 60mm x<br>38mm x<br>170mm | Unknown | 126*78*200mm | 205*76*56mm<br>(H*W*D) | 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 Arc Flashlamp | Xenon Arc Flashlamp | Xenon lamp | Same | |
| Wavelength<br>range | 560-1200nm | 510-1100nm | 510-1200nm | 530nm | Similar | |
| Energy<br>density | 2.4-7.2J/cm2 | 3-6J/cm2 | 1.8~5.1J/cm2 | 2.5J/cm2 Max | Similar | |
| Output<br>energy | 9.9~19.8J | 9~18J | Body<br>lamp<br>cartridge | 11.77~22.21J<br>510-1200nm | Level 1: 7.5J<br>Level 2: 8.5J<br>Level 3: 9.5J<br>Level 4: 11J<br>Level 5: 12J | Similar |
| | | | Facial<br>lamp<br>cartridge | 3.65~7.04J<br>512-1197nm | | |
| | | | Bikini<br>lamp<br>cartridge | 3.84~7.22J<br>511-1200nm | | |
| Spot size | 3.3cm2 | 3cm2 (3cm by 1cm) | Body: 4.2cm2<br>Bikini and face: 2.0cm2 | 3.0cm2 | Similar | |
| Pulse<br>duration | 1.15-6.2ms | 2ms to 10ms | 9.2~11.2ms | 1ms | Different | |
| 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 | |
| Output<br>intensity level | 5 | Unknown | 5 | 5 | Same | |
| Comparison<br>Elements | Subject Device | Primary<br>Predicate<br>Device | Predicate Device | Reference Device | Remark | |
| Software/<br>Firmware/<br>Microprocess<br>or Control? | Yes | Yes | Yes | Yes | Same | |
| Additional features | | | | | | |
| Electrical<br>safety | ANSI<br>ES60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-2-57<br>IEC 60601-2-83 | AAMI<br>IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-57 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-57 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-2-57 | Similar | |
| Eye safety | IEC 62471 | IEC 62471 | Unknown | IEC 62471 | Same | |
| Biocompatibi<br>lity | ISO 10993-5<br>ISO 10993-10 | ISO 10993-5<br>ISO 10993-10 | ISO 10993-5<br>ISO 10993-10 | ISO 10993-5<br>ISO 10993-10…