Hand-held IPL device (JOVS Hair Removal Device)

K220645 · Shenzhen Qianyu Technology Co., Ltd. · OHT · Apr 27, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K220645
• Device Name: Hand-held IPL device (JOVS Hair Removal Device)
• Applicant: Shenzhen Qianyu Technology Co., Ltd.
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Apr 27, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Hand-held IPL device (JOVS Hair Removal Device) is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Device Story

Personal, hand-held light-based hair reduction device; utilizes Xenon lamp to emit Intense Pulsed Light (IPL). Device powered by external adapter; user-operated via finger switch for manual pulse activation. Intended for single-person use in home environment. Direct illumination of skin tissue; light energy targets hair follicles to reduce hair growth without cutting or pulling. Minimal pain reported. Device provides non-invasive hair reduction; benefits include convenience of at-home treatment and reduction of unwanted hair.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence includes electrical safety testing (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83), software verification and validation, and usability testing (IEC 60601-1-6).

Technological Characteristics

Hand-held IPL device; Xenon lamp energy source; wavelength 590-1200nm; energy density 1.83-5.14 J/cm2; spot size 3.5cm2; pulse duration 5.5-9.5 ms. Powered by external adapter. Complies with IEC 60601-1, 60601-1-2, 60601-1-11, 60601-1-6, and 60601-2-83. Software level of concern: moderate.

Indications for Use

Indicated for removal of unwanted body and/or facial hair in over-the-counter, home-use settings.

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 Device (K160968)
• Hand-held IPL device (JOVS Graphene Hair Removal Device) (K214113)

Submission Summary (Full Text)

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April 27, 2022

Shenzhen Qianyu Technology Co., Ltd. % Klem Hou RA Manager Guangzhou Tianke Testing Technology Service Co., Ltd. Room 106-1, 1st Floor, Building A, No. 1, Xin'an Road, Yonghe Economic Zone, Huangpu District Guangzhou, Guangdong 510000 China

Re: K220645

Trade/Device Name: Hand-held IPL device (JOVS 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: OHT Dated: March 2, 2022 Received: March 4, 2022

Dear Klem Hou:

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,

Purva Pandya 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) K220645

Device Name

Hand-held IPL device (JOVS Hair Removal Device)

Indications for Use (Describe)

Hand-held IPL device (JOVS Hair Removal Device) 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)

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# 510(k) Summary - K220645

## 1. Submitter

Shenzhen Qianyu Technology Co., Ltd.

Room 1002, Building A2, KeXing Science Park, No.15 Keyuan Road, Nanshan District,

Shenzhen, Guangdong Province, China

Post code: 518100

Tel.: [phone]

Klem Hou

RA manager

Tel: [phone]

Email: [e-mail]

## 2. Device

Name of Device: Hand-held IPL device (JOVS Hair Removal Device)

Model(s): JR5C-E, JR5C-W, JR5C-OG, JR5-E, JR5-W, JR5-OG

Common or Usual Name: Light Based Over-The-Counter Hair Removal

Classification 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

### 3. Predicate device(s)

| Manufacturer | Predicate Device | 510(k) Number |
|---------------------------------------------|-------------------------------------------------------------|---------------|
| CyDen Ltd | IPulse SmoothSkin Gold Hair<br>Removal Device | K160968 |
| SHENZHEN JVK MEDICAL<br>INSTRUMETS CO., LTD | Hand-held IPL device (JOVS<br>Graphene Hair Removal Device) | K214113 |

#### Device description 4.

Hand-held IPL device (JOVS Hair Removal Device) is a personal, light-based, hair reduction device.

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The device contains a Xenon lamp and provides hair reduction by Intense Pulsed Light (IPL) technology 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 is for single-person use only.

Hand-held IPL device (JOVS Hair Removal Device) includes JR5C-E, JR5C-W, JR5C-OG, JR5-E, JR5-W, JR5-OG. Their intended use, performance, structure design and operation are basically identical, with the different color appearance.

#### 5. Indications for Use

Hand-held IPL device (JOVS Hair Removal Device) is an over-the-counter device intended for removal of unwanted body and/or facial hair.

#### 6. Comparison of Technological Characteristics with the Predicate Device(s)

Hand-held IPL device (JOVS Hair Removal Device) has the same intended use, mode of action and similar operational characteristics as the predicate devices. Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device for its intended use.

Hand-held IPL device (JOVS Hair Removal Device) is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance:

1) K160968(Primary Predicate Device), " IPulse SmoothSkin Gold Hair Removal Device ", manufactured by " CyDen Ltd " in Swansea, United Kingdom

2) K214113, "Hand-held IPL device (JOVS Graphene Hair Removal Device)", manufactured by "SHENZHEN JVK MEDICAL INSTRUMETS CO., LTD " in Guangdong, China

| Comparison<br>Elements | Subject Device | Primary Predicate<br>Device 1<br>(K160968) | Predicate Device 2<br>(K214113) | Remark |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Device name | Hand-held IPL<br>device (JOVS Hair<br>Removal Device) | IPulse SmoothSkin<br>Gold Hair Removal<br>Device | Hand-held IPL<br>device (JOVS Hair<br>Graphene<br>Removal Device) | -- |
| Model | JR5C-E, JR5C-W,<br>JR5C-OG, JR5-E,<br>JR5-W, JR5-OG | -- | JOC-910-Yellow<br>JOC-910-Emerald | -- |
| Comparison<br>Elements | Subject Device | Primary Predicate<br>Device 1<br>(K160968) | Predicate Device 2<br>(K214113) | Remark |
| Classification<br>Name | Laser surgical<br>instrument for use in<br>general and plastic<br>surgery and<br>dermatology | Laser Surgical<br>Instrument For Use<br>In General And<br>Plastic Surgery And<br>In Dermatology | Laser surgical<br>instrument for use in<br>general and plastic<br>surgery and<br>dermatology | SE |
| Product code | OHT | OHT | OHT | SE |
| Regulation<br>number | 878.4810 | 878.4810 | 878.4810 | SE |
| Class | II | II | II | SE |
| Prescription or<br>OTC | OTC | OTC | OTC | SE |
| Indications for<br>use | Hand-held<br>IPL<br>device (JOVS Hair<br>Removal Device) is<br>an over-the-counter<br>device intended for<br>removal<br>of<br>unwanted<br>body<br>and/or facial hair. | The<br>iPulse<br>SmoothSkin Gold<br>Hair<br>Removal<br>System is indicated<br>for the removal of<br>unwanted hair. The<br>iPulse SmoothSkin<br>Gold is also<br>indicated for the<br>permanent<br>reduction in hair<br>regrowth, defined as<br>the long-term,<br>stable reduction in<br>the number<br>of hairs regrowing<br>when measured at 6,<br>9 and 12 months<br>after the completion<br>of a<br>treatment regime. | The Hand-held IPL<br>device (JOVS<br>Graphene<br>Hair<br>Removal Device) is<br>an over-the-counter<br>device intended for<br>removal<br>of<br>unwanted<br>body<br>and/or facial hair. | SE |
| Source Energy | Supplied by external<br>adapter | Supplied by<br>external adapter | Supplied by external<br>adapter | SE |
| Comparison<br>Elements | Subject Device | Primary Predicate<br>Device 1<br>(K160968) | Predicate Device 2<br>(K214113) | Remark |
| Technology | Intense Pulsed Light<br>(IPL) | Intense Pulsed Light<br>(IPL) | Intense Pulsed Light<br>(IPL) | SE |
| Energy<br>medium | Xenon lamp | Xenon lamp | Xenon lamp | SE |
| Pulsing<br>Control | Finger switch | Finger switch | Finger switch | SE |
| Delivery<br>device | Direct illumination<br>to tissue | Direct illumination<br>to tissue | Direct illumination<br>to tissue | SE |
| Wavelength | 590nm〜1200nm | 510-1100nm | 590nm〜1200nm | SE |
| Energy density | 1.83~5.14 J/cm2 | 3-6J/cm2 | 2.9~5.4 J/cm2 | SE |
| Spot size | 3.5cm2 | 3cm2 | 3.4cm2 | SE |
| Output energy | 6.4~18 J | 9.0-18.0J | 9.8~18.4 J | SE |
| Pulse duration | 5.5~9.5 ms | 2~10ms | 5.5~9.5 ms | SE |

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### 7. Performance Data

The following performance data are provided in support of the substantial equivalence determination.

# 1) Electrical Safety and Eye Safety

Electrical safety and Eye safety testing has been performed to, and passed, the following standards:

- ≫ IEC 60601-1-2 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
- > IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical

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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
#### 2) Software Verification and Validation

Software documentation consistent with moderate level of concern is submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications have been met and all software hazards have been mitigated to acceptable risk levels.

#### 3)Usability

Usability testing has been performed to, and passed, the following standards:

- A IEC 60601-1-6 Medical electrical equipment -Part 1-6: General requirements for safety -Collateral standard: Usability
#### Summary

Based on the above performance as documented in this application, the Hand-held IPL device (JOVS Hair Removal Device) is found to have a safety and effectiveness profile that is similar to the predicate device.

#### 8. Conclusions

Based on the comparison of intended use, design, materials and performance, the Hand-held IPL device (JOVS Hair Removal Device) is considered to be substantially equivalent to its predicate device.