Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200

K221214 · Shenzhen Ionka Medical Technology Co., Ltd. · ONF · Sep 21, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K221214
• Device Name: Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200
• Applicant: Shenzhen Ionka Medical Technology Co., Ltd.
• Product Code: ONF · General, Plastic Surgery
• Decision Date: Sep 21, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

IPL home use hair removal device 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 IPL home use hair removal device 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. The device is used for adults with Fitzpatrick skin types I - IV.

Device Story

Hand-held IPL device uses pulsed light to disable hair growth via selective photothermal treatment. Device consists of hand-held applicator and external power supply. User (patient) operates device; requires physician direction and professional training. Device features 3 cm² treatment area, lamp, and skin proximity sensor; pulse triggers only upon full skin contact. Models FZ-608/FZ-608G/FZ-100/FZ-200 include thermoelectric cooling or semiconductor refrigeration to provide cool sensation during treatment. Device output is controlled via finger switch. Healthcare providers use device to facilitate permanent hair reduction, defined as long-term stable reduction in hair regrowth measured at 6, 9, and 12 months post-treatment.

Clinical Evidence

Bench testing only. Performance testing verified wavelength (510-1200 nm), pulse duration (0.5-0.8 ms), output energy, and maximum fluence. Biocompatibility testing (cytotoxicity, sensitization, irritation) performed per ISO 10993-1. Electrical safety and EMC testing conducted per AAMI/ANSI ES60601-1, IEC 60601-2-83, and IEC 60601-1-2.

Technological Characteristics

Xenon arc flashlamp light source; 510-1200 nm wavelength; 3 cm² spot size; 0.5-0.8 ms pulse duration. Includes skin proximity sensor and optical skin tone sensor. Cooling via thermoelectric cooler or semiconductor refrigeration sheet. Powered by external AC/DC adapter (IEC 62368-1 compliant). Hand-held form factor. Software level of concern: Moderate.

Indications for Use

Indicated for adults with Fitzpatrick skin types I-IV for removal of unwanted hair and permanent hair reduction via selective photothermal treatment. Requires physician direction and 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 Device (K160968)
• Hee HR Mini (K170269)
• IPL Hair Removal Device (K213558)
• Aimanfun Lumea Comfort, A-3588 (K212907)

Submission Summary (Full Text)

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September 21, 2022

Shenzhen IONKA Medical Technology Co., Ltd. % Amos Zou RA Manager Shenzhen CT Bio-Tech co., Ltd Room 408, Comprehensive Building, Building 6, Xusheng Building, Xixiang street, Baoan District Shenzhen, Guangdong 518126 China

Re: K221214 Trade/Device Name: Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 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: May 31, 2022 Received: May 31, 2022

Dear Amos Zou:

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

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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 mediation-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 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) K221214

Device Name

Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608,FZ-608G,FZ-100,FZ-200

Indications for Use (Describe)

IPL home use hair removal device 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 IPL home use hair removal device 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.

The device is used for adults with Fitzpatrick skin types I - IV.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 21 CFR 807.92

### Submitter of 510(K): 1.

| Sponsor | |
|-------------------|-------------------------------------------------------------------------|
| Company Name: | Shenzhen IONKA Medical Technology Co., Ltd. |
| Address: | Room 601, No. 3, Jiazitang Second Industrial Zone, Jiazitang Community, |
| | Fenghuang Street, Guangming District, Shenzhen, 518132,China |
| Contact person: | Mr. Chen Dongfa |
| TEL: | [phone] |
| FAX: | [phone] |
| E-mail: | [e-mail] |
| Date of Prepared: | August 31, 2022 |

### Application Correspondent:

| Company Name: | Shenzhen CT Bio-Tech co., Ltd |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Address: | Room 408,Comprehensive Building,Building 6,Xusheng Building,Xixiang<br>street,Baoan District,Shenzhen,,Guangdong.518126,China |
| Contact person: | Amos Zou |
| TEL: | [phone] |
| E-mail: | [e-mail] |
| Date of Prepared: | August 31, 2022 |

### 2. Proposed Device and code:

| Device Trade Name: | Hand-held IPL device (IPL Home Use Hair Removal Device)<br>Model:FZ-608, FZ-608G, FZ-100, FZ-200 |
|------------------------------|--------------------------------------------------------------------------------------------------|
| Regulation Medical Specialty | General & Plastic Surgery |

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| Product Code: | ONF |
|-------------------|--------------------------------------------------------------------------------------|
| Regulation Name | Laser surgical instrument for use in general and plastic surgery and in dermatology. |
| Common Name | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect |
| Regulation number | 21 CFR 878.4810 |
| Device Class | II |

#### 3. Predicate Device:

| 510(K) | Trade or Proprietary or Model Name | Manufacturer |
|---------|--------------------------------------------|---------------------------------|
| K160968 | Ipulse Smoothskin Gold Hair Removal Device | Cyden Limited |
| K170269 | Hee HR Mini | Oriental Inspiration<br>Limited |
| K213558 | IPL Hair Removal Device | Ulike Co., Ltd |
| K212907 | Aimanfun Lumea Comfort, A-3588 | Kam Yuen Plastic Products Ltd |

#### 4. Description of Proposed Device:

The Hand-held IPL device are pulsed light hair removal device. Light-based hair removal is based on the theory of selective photosynthesis in which optical energy is used to disable hair growth. The Hand-held IPL device devices are composed of a hand held applicator and an external power supply. The spot size (treatment area) in the Hand-held IPL device devices is 3 cm², The device contains a lamp, a skin proximity sensor. If the Hand-held IPL device is not properly applied (in full contact with the skin) , the Hand-held IPL device will not trigger a pulse.

The main unit FZ-608 and FZ-608G can only be supplied by the power adaptor (model: SHCSP2402000FUS), The main unit FZ-100 and FZ-200 can only be supplied by the power adaptor (model: SHCY-SP2401500EUS), the adapters have been approved in accordance with IEC 62368-1 and tested with equipment, considering as a part of this ME equipment.

FZ-608 and FZ-608G are identical except for model No. and enclosure colour.

The patient is an intended operator.

#### న. Indications for Use

IPL home use hair removal device 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 IPL home use hair removal device 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. The device is used for adults with Fitzpatrick skin types I - IV.

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### Technical and Performance 6.

The following table compares the device to the predicate device with basic technological characteristics.

| Elements of<br>comparison | Subject Device<br>1# K221214 | Subject Device<br>2# K221214 | Subject Device<br>3# K221214 | Predicate Device<br>1# K160968 | Predicate Device<br>2# K170269 | Predicate Device<br>3# K212907 | Predicate Device<br>4# K213558 | Remark |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Device<br>Name and<br>Model | IPL home use hair<br>removal device<br>FZ-608&FZ-608G | IPL home use hair<br>removal device<br>FZ-100 | IPL home use hair<br>removal device<br>FZ-200 | Ipulse<br>Smoothskin<br>Gold Hair<br>Removal Device | Hee HR Mini | Aimanfun Lumea<br>Comfort, A-3588 | IPL Hair<br>Removal Device | / |
| Manufacturer | Shenzhen IONKA<br>Medical Technology<br>Co., Ltd. | Shenzhen IONKA<br>Medical Technology<br>Co., Ltd. | Shenzhen IONKA<br>Medical Technology<br>Co., Ltd. | Cyden Limited | Oriental<br>Inspiration<br>Limited | Kam Yuen<br>Plastic Products<br>Ltd | Ulike Co., Ltd | / |
| Classification<br>n Product<br>Code | ONF | ONF | ONF | OHT, GEX | OHT | ONF | ONF | Same |
| Light source | Xenon Arc<br>Flashlamp | Xenon Arc<br>Flashlamp | Xenon Arc<br>Flashlamp | Xenon Arc<br>Flashlamp | Xenon Arc<br>Flashlamp | Xenon Arc<br>Flashlamp | Xenon Arc<br>Flashlamp | Same |
| | | | | | | | | similar |
| Wavelength<br>(nm) | 510 - 1200 | 510 - 1200 | 510 - 1200 | 510 - 1100 | 475 - 1200 | 475 - 1200 | 550 - 1200 | Note 1# |
| | | | | | | | | Same |
| Spot size | 3 cm2 | 3 cm2 | 3 cm2 | 3 cm2 | 3 cm2 | 3 cm2 | 3.3 cm2 | similar |
| Max fluence | 3.33 J/cm2 | 5.43 J/cm2 | 4.5 J/cm2 | 6 J/cm2 | 5 J/cm2 | 4.5 J/cm2 | 6 J/cm2 | Note 2# |
| | Level 1: 4.16J | Level 1: 5.7J | Level 1: 4.6J | | | | | Similar |
| Energy<br>output | Level 2: 4.36J<br>Level 3: 5.1J | Level 2: 6.5J<br>Level 3: 8.06J | Level 2: 5.7J<br>Level 3: 6.63J | 9 - 18 J | 15 J max | 7 - 13.5 J | 7 – 20 J | |
| Elements of<br>comparison | Subject Device<br>1# K221214 | Subject Device<br>2# K221214 | Subject Device<br>3# K221214 | Predicate Device<br>1# K160968 | Predicate Device<br>2# K170269 | Predicate Device<br>3# K212907 | Predicate Device<br>4# K213558 | Remark |
| | Level 4: 6.1J<br>Level 5: 6.96J<br>Level 6: 7.96J<br>Level 7: 8.63J<br>Level 8: 9.13J<br>Level 9: 10J | Level 4: 9.73J<br>Level 5: 11.96J<br>Level 6: 14.1J<br>Level 7: 15.13J<br>Level 8: 15.33J<br>Level 9: 16.26J | Level 4: 8.66J<br>Level 5: 11.3J<br>Level 6: 13.5J | | | | | Note 3# |
| Energy<br>density range | $1.4 - 3.3 J/cm^2$ | $1.9 - 5.4 J/cm^2$ | $1.5 - 4.5 J/cm^2$ | $3 - 6 J/cm^2$ | Unknown | $2.3 - 4.5 J/cm^2$ | $2.1 - 6 J/cm^2$ | Similar<br>Note 4# |
| Pulse<br>duration | 0.5 - 0.8 ms | 0.5 - 0.8 ms | 0.5 - 0.8 ms | 2 - 10 ms | 0.5 - 0.8 ms | 3 ms | 3 ms | similar<br>Note 5# |
| Skin contact<br>sensor | Yes | Yes | Yes | Yes | Yes | Yes | Yes | same |
| Cooling<br>system | Yes (thermoelectric<br>cooler) | Yes (thermoelectric<br>cooler) | Yes (semiconductor<br>refrigeration sheet) | No | No | Yes<br>(thermoelectric<br>cooler) | No | same |
| Treatment<br>schedule | 1 X/week for 12<br>weeks | 1 X/week for 12<br>weeks | 1 X/week for 12<br>weeks | 1 X/week for 12<br>weeks | 1X every 2 weeks<br>for 4 treatments,<br>1X every 4 weeks<br>for treatments 5-7,<br>then as needed | 1 X/week for 12<br>weeks | 1 X/week for 12<br>weeks | Same |
| Use<br>classification | Rx | Rx | Rx | OTC | OTC | Rx | Rx | Same |
| Ice-sensing<br>function | Yes | Yes | No | No | No | Yes | No | Same as<br>K212907<br>Note 6# |
| Elements of<br>comparison | Subject Device<br>1# K221214 | Subject Device<br>2# K221214 | Subject Device<br>3# K221214 | Predicate Device<br>1# K160968 | Predicate Device<br>2# K170269 | Predicate Device<br>3# K212907 | Predicate Device<br>4# K213558 | Remark |
| Delivery<br>Device | Direct Illumination to<br>Tissue | Direct Illumination to<br>Tissue | Direct Illumination to<br>Tissue | Direct<br>Illumination to<br>Tissue | Direct<br>Illumination to<br>Tissue | Direct<br>Illumination to<br>Tissue | Direct<br>Illumination to<br>Tissue | same |
| Pulsing<br>Control | Finger switch | Finger switch | Finger switch | Finger switch | Finger switch | Finger switch | Finger switch | same |
| Skin Tone<br>Sensor | Optical Measurement<br>Integral to device.<br>Continuous<br>measurement. | Optical Measurement<br>Integral to device.<br>Continuous<br>measurement. | Optical Measurement<br>Integral to device.<br>Continuous<br>measurement. | Optical<br>Measurement<br>Integral to<br>device.<br>Continuous<br>measurement. | Optical<br>Measurement<br>Integral to device.<br>Continuous<br>measurement. | Optical<br>Measurement<br>Integral to<br>device.<br>Continuous<br>measurement. | Optical<br>Measurement<br>Integral to device.<br>Continuous<br>measurement. | same |
| Specific<br>Indications<br>for<br>Use | IPL home use hair<br>removal device is<br>indicated for patient<br>removal of unwanted<br>hair by using a<br>selective<br>photothermal<br>treatment under the<br>direction of a<br>physician, after<br>training by a<br>healthcare<br>professional. The IPL<br>home use hair | IPL home use hair<br>removal device is<br>indicated for patient<br>removal of unwanted<br>hair by using a<br>selective<br>photothermal<br>treatment under the<br>direction of a<br>physician, after<br>training by a<br>healthcare<br>professional. The IPL<br>home use hair | IPL home use hair<br>removal device is<br>indicated for patient<br>removal of unwanted<br>hair by using a<br>selective<br>photothermal<br>treatment under the<br>direction of a<br>physician, after<br>training by a<br>healthcare<br>professional. The IPL<br>home use hair | The iPulse<br>SmoothSkin<br>Gold Hair<br>Removal System<br>is indicated for<br>the removal of<br>unwanted hair.<br>The iPulse<br>SmoothSkin<br>Gold is also<br>indicated for the<br>permanent<br>reduction in hair<br>regrowth | HEE HR Mini is<br>an over-the-<br>counter device<br>intended for the<br>removal of<br>unwanted hair.<br>The HEE HR Mini<br>is also intended for<br>permanent<br>reduction in hair<br>regrowth, defined<br>as a long-term,<br>stable reduction in<br>the number of | The Aimanfun<br>Lumea Comfort<br>(Model: A-3588)<br>is indicated for<br>patient removal<br>of unwanted hair<br>by using a<br>selective<br>photothermal<br>treatment under<br>the direction of a<br>physician, after<br>training by a<br>healthcare | The IPL Hair<br>Removal Device<br>(Model: UI04A,<br>UI04B, UI04C) is<br>indicated for<br>patient removal<br>of unwanted hair<br>by using a<br>selective<br>photothermal<br>treatment under<br>the direction of a<br>physician, after<br>training by a | Same |
| Elements of<br>comparison | Subject Device<br>1# K221214 | Subject Device<br>2# K221214 | Subject Device<br>3# K221214 | Predicate Device<br>1# K160968 | Predicate Device<br>2# K170269 | Predicate Device<br>3# K212907 | Predicate Device<br>4# K213558 | Remark |
| | removal device is<br>also intended for<br>permanent reduction<br>in unwanted hair.<br>Permanent hair<br>reduction is defined<br>as the long-term<br>stable reduction in<br>the number of hairs<br>regrowing when<br>measured at 6. 9. and<br>12 months after the<br>completion of a<br>treatment regimen. | removal device is<br>also intended for<br>permanent reduction<br>in unwanted hair.<br>Permanent hair<br>reduction is defined<br>as the long-term<br>stable reduction in<br>the number of hairs<br>regrowing when<br>measured at 6. 9. and<br>12 months after the<br>completion of a<br>treatment regimen. | removal device is<br>also intended for<br>permanent reduction<br>in unwanted hair.<br>Permanent hair<br>reduction is defined<br>as the long-term<br>stable reduction in<br>the number of hairs<br>regrowing when<br>measured at 6. 9. and<br>12 months after the<br>completion of a<br>treatment regimen. | defined as the<br>long-term, stable<br>reduction in the<br>number of hairs<br>regrowing when<br>measured at 6, 9<br>and 12 months<br>after the<br>completion of a<br>treatment<br>regime. | hairs regrowing<br>when measured at<br>6, 9, and 12<br>months after the<br>completion of<br>treatment regimen. | professional. The<br>Aimanfun Lumea<br>Comfort 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<br>regrowing when<br>measured at 6. 9.<br>and 12 months<br>after the<br>completion of a<br>treatment<br>regimen | healthcare<br>professional. The<br>IPL Hair<br>Removal Device<br>is also intended<br>for 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<br>regrowing when<br>measured at 6, 9,<br>and 12 months<br>after the<br>completion of a<br>treatment<br>regimen. | |
| | The device is used<br>for adults with<br>Fitzpatrick skin types<br>I – IV. | The device is used<br>for adults with<br>Fitzpatrick skin types<br>I – IV. | The device is used<br>for adults with<br>Fitzpatrick skin types<br>I – IV. | | | | | |

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Version:1.1

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