Aimanfun Lumea Comfort

K190820 · Kam Yuen Plastic Products , Ltd. · OHT · Oct 2, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K190820
• Device Name: Aimanfun Lumea Comfort
• Applicant: Kam Yuen Plastic Products , Ltd.
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Oct 2, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aimanfun Lumea Comfort (Model: A-2788) is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The Aimanfun Lumea Comfort is also intended for permanent reduction in unwanted hair. Permanent hair reduction is 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 regimen.

Device Story

Aimanfun Lumea Comfort is a handheld, portable IPL device for permanent hair reduction. It uses a xenon arc flashlamp to emit light (475-1200nm) to heat hair roots via selective photothermolysis. The device features 5 adjustable energy levels (7-13.5J) and a skin proximity sensor that prevents pulse emission unless full skin contact is achieved. It is operated by a patient under the direction of a physician after professional training. The device is used in a home or clinical setting. The healthcare provider oversees the treatment regimen, while the patient uses the device to deliver pulses via a finger switch. The device benefits patients by providing a long-term stable reduction in hair regrowth.

Clinical Evidence

Bench testing only. The device was evaluated for electrical safety (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57) and biocompatibility (ISO 10993-5, ISO 10993-10). No clinical data provided.

Technological Characteristics

Handheld IPL device; Xenon arc flashlamp source; 475-1200nm spectrum; 3.0 cm2 spot size; 4.5 J/cm2 max fluence; 3ms pulse duration; 5 energy levels. Housing material: ABS. Powered by external adapter (100-240 VAC). Compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57. Biocompatibility: ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for patient removal of unwanted hair and permanent hair reduction in adults. Requires use under physician direction following healthcare professional training.

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)
• Perfectsmooth (K161428)
• Lumilisse IPL Hair Remover (K172791)
• Shaser V-MINI RX (K132170)

Submission Summary (Full Text)

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October 2, 2019

Kam Yuen Plastic Products Ltd % Jet Li Regulation Manager Guangzhou KEDA Biological Tech Co., Ltd. 6F. No.1 TianTai road, Science City, LuoGang District Guangzhou, Cn

Re: K190820

Trade/Device Name: Aimanfun Lumea Comfort 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: ONF Dated: March 24, 2019 Received: April 1, 2019

Dear Jet Li:

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 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) K190820

Device Name

The Aimanfun Lumea Comfort (Model: A-2788)

#### Indications for Use (Describe)

The Aimanfun Lumea Comfort (Model: A-2788) is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The Aimanfun Lumea Comfort is also intended for permanent reduction in unwanted hair. Permanent hair reduction is 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 regimen.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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#### K190820 510(k) Summary

Date of the summary prepared: October 2, 2019

# 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: Kam Yuen Plastic Products Ltd
- � Address: No. 2, Heng Feng Two Road, Pu Jin Industrial, Konghou Town, ZhongShan, Guangdong, China
- Phone: [phone] �
- � Fax: [phone]
- � Contact Person (including title): Anna Dan
- � E-mail:[e-mail]

#### Application Correspondent:

- Company: Guangzhou KEDA Biological Tech Co., Ltd. �
- Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhouCity,China �
- � Contact Person: Mr. Jet Li
- � Tile: Regulation Manager
- � Tel: [phone]
- � Email: [e-mail]

#### 2. Subject Device Information

- � Trade Name: Aimanfun Lumea Comfort, Model: A-2788
- Light based hair removal devices � Common Name:
- Powered Light Based Non-Laser Surgical Instrument With Classification name: �
- Thermal Effect
- General & Plastic Surgery � Review Panel:
- ONF � Product Code:
- 2 � Regulation Class:

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#### 878.4810 � Regulation Number:

#### 3. Predicate Device Information

Predicate device I - IV:

| Sponsor | CyDen Limited | Shen Zhen<br>CosBeauty<br>Co., Ltd | Conair<br>Corporati<br>on | Shaser,<br>Inc. |
|-------------------|--------------------------------------------------|------------------------------------|----------------------------------|----------------------|
| Device Name | iPulse SmoothSkin<br>Gold Hair Removal<br>System | Perfectsmo<br>oth | Lumilisse<br>IPL Hair<br>Remover | Shaser V-<br>MINI RX |
| 510(k) Number | K160968 | K161428 | K172791 | K 132170 |
| Product Code | OHT | OHT | OHT | ONF |
| Regulation Number | 878.4810 | 878.4810 | 878.4810 | 878.4810 |
| Regulation Class | Class II | Class II | Class II | Class II |

#### 4. Device Description

Aimanfun Lumea Comfort, Model: A-2788 is a light-based device for long-term hair removal. It is intended for the removal of unwanted hair and permanent reduction in hair regrowth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the IPL technology with lower energy level, including 5 Levels of output energy . Intense Pulsed light technology is able to achieve long-term hair removal results at a fraction of the energy level used in other light-based hair removal equipment. The size of the device is about 138.9*82*47.3mm (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. 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 triggered a pulse emitting.

#### 5. Intended Use / Indications for Use

The Aimanfun Lumea Comfort (Model: A-2788) is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician,after training by a healthcare professional. The Aimanfun Lumea Comfort is also intended for permanent reduction in unwanted hair.

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| Sponsor: | Kam Yuen Plastic Products Ltd |
|-----------------|-----------------------------------------------------------|
| Subject Device: | Aimanfun Lumea Comfort, Model: A-2788 |
| File No.: | 510(k) submission report (V1.0), Chapter 6 510(k) Summary |

Permanent hair reduction is 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 regimen.

#### 6. Design

Hand-held IPL device (Aimanfun Lumea Comfort) consists of main unit and adaptor. It is a portable device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL) which is a xenon lamp.

The size of the device is about 138.9*82*47.3mm (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.

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 triggered a pulse emitting.

#### 7. Materials

There is one part of patient directly contacting component 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 of unit | ABS | Surface-contacting<br>device: skin | Maximum 30<br>minutes(< 24hours) |

The Nature of body contact is surface, skin contact. And the contact duration is less than 24 hours. According to Table 1 - Initial evaluation tests for consideration in ISO 10993-1, the applicable biological effect is:

- � Cytotoxicity
- � Sensitization
- � Irritation or intracutaneous reactivity

#### 8. Physical characteristics

| Basic Unit Characteristics | |
|--------------------------------|-----------------------------------------------------------------------------------------|
| Compliance* with 21 CFR 898 | No |
| Main Unit Weight | 200g |
| Main Unit Dimension | 138.9*82*47.3mm |
| Housing Materials of main unit | ABS |
| Indicator | Indicates power information/skin detection<br>information, gear conversion information. |

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Kam Yuen Plastic Products Ltd Sponsor: Subject Device: Aimanfun Lumea Comfort, Model: A-2788 File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary

| Time Range (minutes) | Work for 60 minutes and stop for 10 minutes |
|----------------------------------------------|------------------------------------------------------------------|
| Environment for operation | Temperature: 5°C~45°C<br>Humidity: 20~65% |
| Storage and Transport Conditions | Temperature: 0°C~40°C<br>Humidity: 10~90% |
| Compliance with Voluntary<br>Standards | Yes, Comply with IEC 60601-1, IEC 60601-1-2,<br>IEC 60601-2-57 . |
| Patient leakage current | Comply with IEC 60601-1 |
| Power Source | Supplied by external adapter |
| Software/Firmware/Microprocessor<br>Control? | Yes |
| <b>Specification</b> | |
| Output Intensity Level | 5 steps |
| Output energy | 7-13.5J |
| Emitted Light Spectrum | 475nm~1200nm Max |
| Pulse width range | 3 ms |
| Power Supply | 100-240 VAC, 50/60Hz, 0.5A |
| Technology | IPL |

#### 9. Test Summary

Aimanfun Lumea Comfort, Model: A-2788 has been evaluated the safety and performance by lab bench testing as following:

IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2012 +A1:2012

IEC 60601-1-2. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2014

IEC 60601-1-11:2015 Medical Electrical Equipment –Part 1: 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 60601-2-57:2011 Medical electrical equipment –Part 2-57: Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

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ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.

ISO 10993-10:2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff

### 10. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, and intended use of Aimanfun Lumea Comfort, model: A-2788 is substantially equivalent to the predicate devices quoted above. Aimanfun Lumea Comfort relies on the same technology as both predicate devices : Intense Pulsed Light (IPL). Their energy source is the same: Xenon Arc Flashlamp.

The safety and efficacy of IPL treatment for hair reduction are governed by the following parameters:

• Wavelength of the emitted light (spectrum): Defines the interaction with specific chromophores (the part of the molecule responsible for its color) such as melanin, hemoglobin and water. Aimanfun Lumea Comfort and the predicate devices utilize the same spectrum as the Perfectsmooth predicate device (475-1200nm).

• Fluence/flux - defines the energy per area (e.g. joules per cm²) for the treatment. Aimanfun Lumea Comfort and the predicate devices deliver the same maximum energy (4.5 joules/cm2).

The following technological differences exist between the subject and predicate devices I to III:

- Prescription use for subject device:
- । No Skin tone sensing circuit; but subject device and predicate devices IV is the same design on this feature and both of them are also for prescription use.

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 | Primary Predicate<br>Device I | Predicate Device<br>II | Predicate Device<br>Device III | Predicate<br>Device IV | Verdict |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Manufacturer | Kam Yuen Plastic<br>Products Ltd | CyDen Limited. | Shen Zhen<br>CosBeauty Co.,<br>Ltd | Conair<br>Corporation | Shaser, Inc. | -- |
| Product Name | Aimanfun Lumea<br>Comfort, Model: A-<br>2788 | iPulse SmoothSkin<br>Gold Hair Removal<br>System | Perfectsmooth | Lumilisse IPL<br>Hair Remover | Shaser V-MINI<br>RX | -- |
| 510(K) No. | Applying | K160968 | K161428 | K172791 | K 132170 | -- |
| Indicationsfor<br>Use | The Aimanfun Lumea<br>Comfort (Model: A-<br>2788) is indicated for<br>patient removal of<br>unwanted hair by using<br>a selective<br>photothermal<br>treatment under the<br>direction of a<br>physician, after<br>training by a<br>healthcare<br>professional. The<br>Aimanfun Lumea<br>Comfort is also<br>intended for<br>permanent reduction in<br>unwanted hair.<br>Permanent hair<br>reduction is defined as<br>the long-term stable<br>reduction in the<br>number of hairs | The iPulse<br>SmoothSkin Gold<br>Hair 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 of hairs | The IPL Hair<br>Removal Device<br>Joy Version is an<br>over-the-counter<br>device intended for<br>removal of<br>unwanted hair<br>such as but not<br>limited to small<br>areas such as<br>underarm and<br>facial hair below<br>the chin line and<br>large areas such<br>as legs. | The Lumilisse IPL<br>(Intense Pulsed<br>Light) Hair<br>Remover is an<br>over-the-counter<br>device intended<br>for the removal of<br>unwanted hair. | The Shaser V-<br>MINI RN Hair<br>Removal System<br>is intended to<br>provide<br>phototherapeutic<br>light to the body<br>and is generally<br>indicated to treat<br>dermatological<br>conditions. It is<br>also intended for<br>removal of<br>unwanted<br>hair by using a<br>selective<br>photothermal<br>treatment. The<br>Shaser V-MINI<br>RN Hair Removal<br>System is<br>indicated for<br>patient removal of | SE<br>Note 1 |
| Elements of<br>Comparison | Subject Device | Primary Predicate<br>Device I | Predicate Device<br>II | Predicate<br>Device III | Predicate<br>Device IV | Verdict |
| | regrowing when<br>measured at 6. 9. and<br>12 months after the<br>completion of a<br>treatment regimen. | regrowing when<br>measured at 6, 9<br>and 12 months after<br>the completion of a<br>treatment regime. | | | unwanted hair by<br>using a selective<br>photothermal<br>treatment under<br>the direction of a<br>physician. after<br>training by a<br>healthcare<br>professional. It<br>is also indicated<br>for the removal of<br>unwanted body<br>and/or facial hair<br>in adults with<br>Fitzpatrick skin<br>types I - VI. The<br>Shaser V-MINI<br>RX Hair Removal<br>System 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<br>stable reduction<br>in the number of<br>hairs regrowing<br>when measured<br>at 6, 9, and 12<br>months after the<br>completion of a | |
| Elements of<br>Comparison | Subject Device | Primary Predicate<br>Device I | Predicate Device<br>II | Predicate<br>Device III | Predicate<br>Device IV | Verdict |
| | | | | | treatment<br>regimen. | |
| IFU Type | Prescription use | Over-The-Counter | Over-The-Counter | Over-The-<br>Counter | Prescription use | SE<br>Note 2 |
| Classification<br>Product Code | ONF | OHT | OHT | OHT | ONF | SE |
| Device Type | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed<br>Light | | SE |
| | Device Design | | | | | |
| Power source | an external power<br>supply | AC Mains | an external power<br>supply | an external power<br>supply | Battery charger | SE |
| Light source | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc<br>Flashlamp | Xenon Arc<br>Flashlamp | SE |
| Wavelength | 475~1200nm | 510nm~1100nm | 475nm~1200nm | 550-1200 nm | 400~1200nm | SE |
| Spot Size | 3.0 cm2 | 3 cm2 | 4.5 cm2 | About 3 cm2 | 2 cm2 | SE |
| Max. Fluence<br>(J/cm²) | 4.5 J/cm² | 3-6 J/cm² | 4.7 J/cm² | 4.5 J/cm² | 6-10 J/cm² | SE |
| Pulse duration | 3 milliseconds | 2-10 milliseconds | 11-13 milliseconds | - | - | SE |
| Elements of<br>Comparison | Subject Device | Primary Predicate<br>Device I | Predicate Device<br>II | Predicate<br>Device III | Predicate<br>Device IV | Verdict |
| | | | | | | Note 3 |
| Output energy | 7-13.5 J | 9-18 J | < 22 J | 6-13.5 J (based<br>on its light<br>intensity 2.0 J cm²<br>-4.5 J/cm²) | < 20 J | SE<br>Note 4 |
| Pulsing Control | Finger switch | Finger switch | Finger switch | Finger switch | Finger switch | SE |
| Delivery Device | Direct Illumination to<br>Tissue | Direct Illumination to<br>Tissue | Direct Illumination to<br>Tissue | Direct Illumination<br>to Tissue | Direct Illumination<br>to Tissue | SE |
| Software<br>Control | Yes | Yes | Yes | Yes | Yes | SE |
| | FDA-Recognized Standards | | | | | |
| | | | | IEC 60601-1 | IEC 60601-1 | |
| | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | IEC 60601-1-2 | IEC 60601-1-2 | |
| Electrical<br>safety, EMC, | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-2-57 | IEC 60601-2-57 | |
| Biological<br>Evaluation | IEC 60601-1-11 | IEC 62471 | IEC 60601-2-57 | IEC 62471 | IEC 62471 | SE |
| | IEC 60601-2-57 | ISO 10993-5 | IEC 62471 | ISO 10993-5 | ISO 10993-5 | |
| | ISO 10993-5 | ISO 10993-10 | ISO 10993-5 | ISO 10993-10 | ISO…