IPL Hair Removal Device Joy Version

K173813 · Shen Zhen Cosbeauty Co., Ltd. · OHT · Sep 7, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K173813
• Device Name: IPL Hair Removal Device Joy Version
• Applicant: Shen Zhen Cosbeauty Co., Ltd.
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Sep 7, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IPL Hair Removal Device Joy Version 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. The device is used for adults with Fitzpatrick skin types I – IV.

Device Story

Home-use IPL hair removal device; utilizes Xenon lamp to emit light pulses (510-1200nm) to heat hair follicles; reduces hair growth without cutting/pulling. Operated by user via finger switch; includes treatment window head, facial adaptor, and external power supply. Features skin proximity sensor to prevent pulse emission unless in full contact with skin. Three lamp cartridges (body, face, bikini) with varying spot sizes (4.2cm² or 2cm²) and energy levels. User selects intensity level; device provides visual feedback on power/intensity. Benefits include permanent hair reduction with minimal pain. Used in home environment; intended for adults.

Clinical Evidence

Bench testing only. Electrical safety (IEC 60601-1, IEC 60601-2-57) and electromagnetic compatibility (IEC 60601-1-2) testing performed. Usability study (OTC study) conducted with 78 subjects demonstrated that lay users can correctly self-select, operate the device, and understand labeling, contraindications, and instructions for use.

Technological Characteristics

IPL device; Xenon arc flashlamp; 510-1200nm spectrum; 5 intensity levels; max fluence 5.1 J/cm²; pulse duration 9.2-11.2ms. Housing/lamp cartridge material: ABS (biocompatible per ISO 10993). Power: 100-240V AC external adapter. Connectivity: None. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57. Microprocessor-controlled.

Indications for Use

Indicated for removal of unwanted hair and permanent reduction in hair regrowth in adults with Fitzpatrick skin types I-IV.

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)
• PerfectSmooth (K161428)

Submission Summary (Full Text)

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September 7, 2018

Shen Zhen CosBeauty Co., Ltd Ms. Iris Fung Regulation manager SGS-CSTC Standards Technical Services Co., Ltd. 198 KEZHU Road, SCIENTECH Park Guangzhou Guangzhou. Cn

Re: K173813

Trade/Device Name: IPL Hair Removal Device Joy Version 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: August 28, 2018 Received: August 31, 2018

Dear Ms. Iris Fung:

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/cfpmr/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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Jennifer Stevensor

For Binita S. Ashar, M.D., M.B.A., F.A.C.S Director Division of Surgical Devices Office of Device Evaluation 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) K173813

#### Device Name

IPL Hair Removal Device Joy Version, Model: CB-027

Indications for Use (Describe)

The IPL Hair Removal Device Joy Version 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. The device is used for adults with Fitzpatrick skin types I - IV.

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

# Date of the summary prepared: September 7, 2018

# 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: Shenzhen CosBeauty Technology Co., Ltd.
- Address: UnitA-3F, Qiao De Industrial Park, Tian Liao, Guang Ming District, Shenzhen, � China
- Phone: [phone] �
- � Fax: [phone]
- � Contact Person (including title): Nicole Hu
- E-mail: [e-mail] �

# Application Correspondent:

- � SGS-CSTC Standards Technical Services Co., Ltd.
- Address: 198 KEZHU Road, SCIENTECH Park Guangzhou Economic & Technology �

Development

District, Guangzhou, Guangdong, CHINA

- � Contact Person: Ms. Iris Fung
- Tel: [phone] �
- Email: [e-mail] �

#### 2. Subject Device Information

- � Trade Name: IPL Hair Removal Device Joy Version, Model: CB-027
- Light Based Over-The-Counter Hair Removal � Common Name:
- Laser surgical instrument for use in general and plastic � Classification name: surgery and in dermatology
- General & Plastic Surgery � Review Panel:
- ОНТ Product Code: �
- 2 � Regulation Class:
- 878.4810 � Regulation Number:

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# 3. Predicate Device Information

| Sponsor | Cyden Limited | Shenzhen CosBeauty<br>Technology Co., Ltd. |
|----------------------|-----------------------------------------------------|--------------------------------------------|
| Device Name | Ipulse<br>Smoothskin Gold<br>Hair Removal<br>Device | PerfectSmooth |
| 510(k) Number | K160968 | K161428 |
| Product Code | ONF | OHT |
| Regulation<br>Number | 878.4810 | 878.4810 |
| Regulation Class | 2 | 2 |

### 2. Device Description

IPL Hair Removal Device Model: CB-027, a small over-the-counter, is a home-use device for the permanent 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. A personal Light-Based Hair Removal System. Emission is by finger switch. Device includes a treatment window head, a facial adaptor and battery charger/AC cord.It is used AC Powered(100-240 V AC; 50/60 Hz).The weight of the device is 402g, and the size is 126 x 78 x 200mm (H x W x D).The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.

# 5. Intended Use / Indications for Use

The IPL Hair Removal Device Joy Version 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. The device is used for adults with Fitzpatrick skin types I – IV.

#### 6. Design

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 triggerred a pulse emitting. Body lamp cartridge can be used for body hair below the neck. It can cover an area of 4.2cm2, and it is specially designed for large areas on legs, arms, back and abdomen. It can remove hair in a large scope rapidly. Do not use Body lamp cartridge on face. A filter has been installed in the face lamp cartridge. It can cover an area of 2cm2, and it can be used to remove hair on upper lip, chin and sideburns. Do not use this lamp cartridge on the areas around eyes or near eyelid. The product can flash for 300,000 times, and it shall not be used when the flash counter is displaying "000000".

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# 7. Materials

There are two patient- directly contracting components in the subject device as the following list.

| Component of<br>Device Requiring<br>Biocompatibility | Material of<br>Component | Body Contact<br>Category<br>(ISO 10993-1) | Contact Duration<br>(ISO 10993-1) |
|------------------------------------------------------|--------------------------|-------------------------------------------|-----------------------------------|
| Housing | ABS | Surface-contacting<br>device: skin | Maximum 30<br>minutes(< 24hours) |
| Plastic plate of lamp<br>cartridge | ABS | Surface-contacting<br>device: skin | Maximum 30<br>minutes(< 24hours) |

Both materials is identical to the material of the device PerfectSmooth, which is cleared by FDA with K161428, produced by us. So these parts' biocompatibility is safe.

# 8. Physical characteristics

| Basic Unit Characteristics | |
|-------------------------------------------|--------------------------------------------------------------|
| Compliance* with 21 CFR 898 | No |
| Main Unit Weight | 402g |
| Main Unit Dimension | 126*78*200mm |
| Housing Materials of main unit | PC2805 |
| Indicator | Indicates power information, intensity level information. |
| Environment for operation | Temperature: 5°C~35°C |
| Storage and Transport Conditions | Temperature: -10°C~55°C |
| 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 Control? | Yes |
| Specification | |
| Output Intensity Level | 5 |
| Output energy with body lamp cartridge | Level 1: 11.77J |
| | Level 2: 14.12J |
| | Level 3: 17.12J |
| | Level 4: 19.95J |
| | Level 5: 22,21J |
| Output energy with facial lamp cartridge | Level 1: 3.65J |
| | Level 2: 4.59J |
| | Level 3: 5.33J |
| | Level 4: 6.16J |
| | Level 5: 7.04J |
| Output energy with bikini lamp cartridge | Level 1: 3.84J |
| | Level 2: 4.92J |

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| | Level 3: 5.43J |
|---------------------------------|------------------------------------------------|
| | Level 4: 6.23J |
| | Level 5: 7.22J |
| Emitted Light Spectrum | 510nm~1200nm Max |
| Max Energy density: | 5.1 J/cm², |
| Pulse duration | 9.20~11.20milliseconds |
| Treatment Area (regular window) | Body: 4.2 [cm²], Bikini area and Face: 2 [cm²] |
| Flashes: | 300,000 times |
| Power Supply | 100-240 VAC, 50/60Hz |
| Technology | IPL |

### 10. Test Summary

IPL Hair Removal Device Joy Version, Model: CB-027 has been evaluated the safety and performance by lab bench testing as following:

- � Electrical safety test according to IEC 60601-1 and IEC 60601-2-57 standards
- � Electromagnetic compatibility test according to IEC 60601-1-2 standard
- � Software verification and validation test according to the requirements of the FDA "Guidance for PreMarket Submissions and for Software Contained in Medical Devices"
- � Usability study:

Usability testing (OTC Study) was completed in 78 subjects to evaluate device human factors and label comprehension.

These usability study tests demonstrate that the device and its labeling can meet with the requirement:

1) the lay user can self-select themselves as being appropriate users of this device by the external box labeling, 2) the lay user can apply the treatment safely and correctly according to the instructions for use, and 3) the lay user can understand all indications, contraindications, warnings and precautions, and be able to identify whether they are within any contraindicated group; and be able to understand the user manual.

# 11. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, and intended use of IPL Hair Removal Device Joy Version, model: CB-027 is substantially equivalent to the predicate devices quoted above.

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

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| Elements of<br>Comparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Device Name and<br>Model | IPL Hair Removal Device<br>Joy Version, Model: CB-<br>027 | iPulse SmoothSkin<br>Gold | PerfectSmooth (CB-<br>014) | -- | |
| 510(k) Number | Applying | K160968 | K161428 | -- | |
| Manufacturer | Shenzhen CosBeauty<br>Technology Co., Ltd. | CyDen Ltd | Shenzhen CosBeauty<br>Technology Co., Ltd. | -- | |
| Intended Use | The IPL Hair Removal<br>Device Joy Version is<br>indicated for the removal<br>of unwanted hair. The<br>device is also indicated for<br>the permanent reduction<br>in hair regrowth, defined<br>as the long-term, stable<br>reduction in the number of<br>hairs regrowing when<br>measured at 6, 9 and 12<br>months after the<br>completion of a treatment<br>regime. The device is<br>used for adults with<br>Fitzpatrick skin types I –<br>IV. | The iPulse SmoothSkin<br>Gold Hair Removal<br>System is indicated for<br>the removal of<br>unwanted hair. The<br>iPulse SmoothSkin Gold<br>is also indicated for the<br>permanent reduction in<br>hair regrowth, defined<br>as the long-term,<br>stable reduction in the<br>number of hairs<br>regrowing when<br>measured at 6, 9 and 12<br>months after the<br>completion of a<br>treatment regime. | The IPL Hair Removal<br>Device Joy Version is<br>an over-the-counter<br>device intended for<br>removal of unwanted<br>hair such<br>as but not limited to<br>small areas such as<br>underarm and facial hair<br>below the chin line and<br>large areas<br>such as legs. | SE | |
| Source Energy | Supplied by external<br>adapter | AC Mains | an external power<br>supply | SE<br>Note 1 | |
| 'Use'<br>Classification | OTC | OTC | OTC | SE | |
| Device<br>Classification | Class II | Class II | Class II | SE | |
| Device Type | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | SE | |
| Wavelength (nm) | 510nm~1200nm | 510nm~1100nm | 475nm~1200nm | SE<br>Note 2 | |
| Max. Fluence<br>(J/cm2) | 5.1 [Joules/cm²] | 3-6 [Joules/cm²] | 4.7[Joules/cm²] | SE<br>Note 3 | |
| Spot Size (cm2) | Body: 4.2 [cm²], Bikini and<br>Face: 2 [cm²] | 3[cm²] | 4.5[cm²] | SE<br>Note 4 | |
| Pulse duration | 9.20-11.20milliseconds | 2 ms- 10 ms | 11-13milliseconds | SE | |
| Elements of<br>Comparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | SE | |
| Pulsing Control | Finger switch | Finger switch | Finger switch | SE | |
| Number of Output<br>Channels | One channel | One channel | One channel | SE | |
| Output energy<br>AND Energy<br>spectrum | body<br>lamp<br>cartridge<br> | Level 1: 11.77J@<br>510nm~1200nm<br>Level 2: 14.12J@<br>510nm~1200nm<br>Level 3: 17.12J@<br>510nm~1200nm<br>Level 4: 19.95J@<br>510nm~1200nm<br>Level 5: 22,21J@<br>510nm~1200nm | 9- 18J @<br>510nm~1100nm | Level 1: 11.5J @<br>475nm~1200nm<br>Level 2: 15.0J @<br>475nm~1200nm<br>Level 3: 17.0J@<br>475nm~1200nm<br>Level 4: 20.0J@<br>475nm~1200nm<br>Level 5: 22,0J@<br>475nm~1200nm | SE<br>Note 5 |
| | facial<br>lamp<br>cartridge | Level 1: 3.65J@<br>512nm~1197nm<br>Level 2: 4.59J@<br>512nm~1197nm<br>Level 3: 5.33J@<br>512nm~1197nm<br>Level 4: 6.16J@<br>512nm~1197nm<br>Level 5: 7.04J@<br>512nm~1197nm | | | |
| | bikini<br>lamp<br>cartridge | Level 1: 3.84J@<br>511nm~1200nm<br>Level 2: 4.92J@<br>511nm~1200nm<br>Level 3: 5.43J@<br>511nm~1200nm<br>Level 4: 6.23J@<br>511nm~1200nm<br>Level 5: 7.22J @<br>511nm~1200nm | | | |
| Software/Firmware/Microprocessor<br>Control? | Yes | Yes | Yes | SE | |
| 60601Compliance<br>with Voluntary<br>Standards | Yes<br>Comply with IEC 60601-1<br>and IEC 60601-1-2,<br>IEC60601-2-57 | Yes<br>Comply with IEC 60601-<br>1 and IEC 60601-1-2,<br>IEC60601-2-57, | Yes<br>Comply with IEC<br>60601-1 and IEC<br>60601-1-2,IEC60601-2-<br>57 | SE | |
| Elements of<br>Comparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| Compliance* with<br>21 CFR 898 | No | No | No | SE | |
| Weight | 402g | 1Kg | -- | SE<br>Note 1 | |
| Dimensions | 126*78*200mm | 132*35*65mm (H*W*D) | -- | SE<br>Note 1 | |
| Standards | | | | | |
| Biocompatibility | All user directly contacting<br>materials are compliance<br>with ISO10993-5 and<br>ISO10993-10<br>requirements. | All user directly<br>contacting materials are<br>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. | SE | |
| Electrical Safety | Comply with<br>IEC60601-1 and<br>IEC60601-2-57 | Comply with<br>IEC 60601-1 and<br>IEC 60601-2-57 | Comply with<br>IEC 60601-1 and<br>IEC 60601-2-57 | SE | |

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# Comparison in Detail(s):

# Note 1:

"Power Source(s)", "Weight", "Dimensions" is belong to basic characteristics. Although it is a little different from the predicate devices, it will not affect the main function and the intended use of the device. They all also comply with IEC 60601-1 requirements. So the differences will not raise any safety or effectiveness issue.

# Note 2:

Although the Max. Fluence of subject device is a little larger than the one of the predicate device II, but comparing to Predicate device II, the energy density of subject device is less than 10 Joules/cm². And they all comply with IEC 60601-1, IEC 60601-2-57 requirement.

So the differences of function specification will not raise any safety or effectiveness issue.

# Note 3:

Although the wavelength of subject device is a little different from the predicate devices, but they all comply with IEC 60601-1, IEC 60601-2-57 requirement.

And the wavelength of subject device is in the range of the one of predicted devices "PerfectSmooth"

So the differences of function specification will not raise any safety or effectiveness issue.

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# Note 4:

There are three types of "Spot Size (cm2)" of subject device, and there is minor difference between the subject device and the predicate device I, but in predicate device II, there is similar spot size to the size of bikini area /face lamp cartridge in subject device. And they all comply with IEC 60601-1.IEC60601-2-57 requirement.

So the differences of Spot size will not raise any safety or effectiveness issue.

# Note 5:

For IPL light, the energy spectrum is Continuous wavelength range. So even there is minor value difference on the energy spectrum between subject device and predicate devices, but the total energy output density (Max. Fluence value) is similar; and they comply with IEC60601-2-57 Requirement. So the differences of energy spectrum will not raise any safety or effectiveness issue.

And for facial lamp cartridge and bikini lamp cartridge, even the max output energy is lower than the data of predicate devices of K161428/K160968 due to the difference of spot size, but the total energy output density (Max. Fluence value) is similar; and the maximum output energy density of subject device for facial lamp cartridge is about 3.52 J/cm2; and 3.61 J/cm2 for bikini lamp cartridge. Comparing with the predicate device of K 160968, the value range of energy density of predicate device of K160968 is 3-6 J/cm2, which can cover the maximum output energy density of subject device for facial lamp cartridge and bikini lamp cartridge. The phototherapy effectiveness is crucially related to the output energy density and wavelength parameters for IPL, and the output energy of one pulse is minor different to predicate devices because of its spot window size. The spot size of device only affect the treatment target skin area per each pulse flashing, it do not raise any safety or effectiveness issue.

So the differences of output energy for facial lamp cartridge and bikini lamp cartridge will not raise any safety or effectiveness issue.

# Finial Conclusion:

The subject device " IPL Hair Removal Device Joy Version, Model: CB-027" is substantial Equivalence to all predicate devices.