Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200
Device Facts
| Record ID | K230739 |
|---|---|
| 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 | OHT · General, Plastic Surgery |
| Decision Date | May 26, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Device Story
Hand-held IPL device for over-the-counter (OTC) hair removal; utilizes intense pulsed light (IPL) technology via xenon arc flashlamp; operates below skin surface to reduce hair growth; includes hand-held applicator and external power supply; features skin proximity sensor to prevent pulse triggering unless in full contact with skin; user-operated; output controlled by finger switch; intended for home use; benefits include hair reduction with minimal pain; no cutting or pulling involved.
Clinical Evidence
No clinical performance data provided. Bench testing only. Usability/human factors study (OTC study) conducted with 24 subjects to validate label comprehension and safe self-selection/operation by lay users.
Technological Characteristics
Intense Pulsed Light (IPL) using xenon arc flashlamp; 510-1200nm wavelength; 3cm² spot size; energy output 4.16J-16.26J depending on model; finger switch control; skin proximity sensor; external power supply; complies with AAMI/ANSI ES60601-1, IEC 60601-1-11, IEC 60601-2-83, IEC 60601-1-2; biocompatibility per ISO 10993-5 and ISO 10993-10.
Indications for Use
Indicated for removal of unwanted hair and permanent reduction in hair regrowth in adults.
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
- Hand-held IPL device (IPL Home Use Hair Removal Device) (K221214)
Reference Devices
- IPL Hair Removal Device (K222432)
Submission Summary (Full Text)
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May 26, 2023
Shenzhen IONKA Medical Technology Co., Ltd. Yu Yeap Registered Engineer Room 601, No. 3, Jiazitang Second Industrial Zone, Jiazitang Community, Fenghuang Street, Guang Shenzhen, Guangdong 518132 China
Re: K230739
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: OHT Dated: March 7, 2023 Received: March 17, 2023
Dear Yu Yeap:
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Jianting Wang -S
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K230739
Device Name
Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608G, FZ-100, FZ-200
Indications for Use (Describe)
Hand-held IPL device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Type of Use (Select one or both, as applicable)
| | Grantee Direct Activities (FTA-Wide Section 5310 Program) |
|------------------------------------------------------|-----------------------------------------------------------|
| <div> <input checked="true" type="checkbox"/> </div> | Senior Transportation (FTA-Wide Section 5310 Program) |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Sponsor: Shenzhen IONKA Medical Technology Co., Ltd. Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, Subject Device: FZ-608G, FZ-100, FZ-200
## 510(k) Summary K230739
This summary of 510(k) safety and effectiveness information is being submitted in
accordance with the requirements of 21 CFR 807.92.
#### Submitter Information 1
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 Tel.: +86 755 23406031 Fax.: +86 755 23406031 Contact Person (including title): Chen Dongfa (General Manager) E-mail: info@tzwm.com
#### 2 Subject Device Information
Type of 510(k) submission: Traditional 510(k) Device Submission Trade Name: Hand-held IPL device (IPL Home Use Hair Removal Device) Model: FZ-608, FZ-608G, FZ-100, FZ-200 Common Name: Light Based Over-The-Counter Hair Removal Classification Name: Laser surgical instrument for use in general and plastic surgery and indermatology Review Panel: General & Plastic Surgery Product Code: OHT Regulation Number: 878.4810 Regulation Class: 2
#### 3 Predicate device Information
#### Legally existing device K221214
Trade Name: Hand-held IPL device (IPL Home Use Hair Removal Device) Model: FZ-608, FZ-608G, FZ-100, FZ-200 Common Name: Powered Light Based Non-Laser Surgical Instrument WithThermal Effect Classification Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect Review Panel: General & Plastic Surgery Product Code: ONF Regulation Number: 878.4810 Regulation Class: 2
#### Reference device K222432
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Trade Name: IPL Hair Removal Device Model: KCA423, KCA437, KCA439 Common Name: Light Based Over-The-Counter Hair Removal Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Review Panel: General & Plastic Surgery Product Code: OHT Regulation Number: 878.4810 Regulation Class: 2
#### 4 Device Description
The IPL Home Use Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.
The IPL Home Use Hair Removal Device is composed of a hand-held applicator and an external power supply. The spot size (treatment area) in the IPL Home Use Hair Removal Device is 3cm². The device contains a lamp, a skin proximity sensor. If the IPL Home Use Hair Removal Device is not properly applied (in full contact with the skin), the device will not trigger a pulse.
The IPL Home Use Hair Removal Device includes FZ-608, FZ-608G, FZ-100, and FZ-200 four models. Their intended use, performance, structure design and operation are basically identical, with the differences mainly contains product appearance, energy output range and its equipped power supply model. The model difference is embodied in: #1) energy output level of model FZ-608 and FZ-608G has 9 levels, corresponding to an output range of 4.16J~10J; model FZ-100 has 9 levels, corresponding to an output range of 5.7J~16.26J, and model FZ-200 has 6 levels, corresponding to an output range of 4.6J~13,5J; #2) the main unit FZ-608 and FZ-608G can be supplied by the power adaptor (model: SHCSP2402000FUS), and 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.
### 5 Intended Use
IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
#### 6 Complied Standards
Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 complies with the following FDA recognized consensus standards:
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- 区 Electrical safety test according to AAMI/ANSI ES60601-1, IEC60601-1-11 and IEC 60601-2-83 standards
- 区 Electromagnetic compatibility test according to IEC 60601-1-2 standard
- 区 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 区 for Irritation and Skin Sensitization.
#### Device modification description 7
The only modification of subject device is Intended Use. The device has changed to over-the-counter use. Therefore, the User Manual and Box labelling has been adding corresponding use instructions for lay person user.
#### 8 Performance Testing
As the modification of subject device as above, results in no technological characteristics changes, the tests and data utilized to demonstrate safety and efficacy of the predicate device (legally existing device) are suitable for use in the assessment of the subject devices.
As there have been no changes to the performance of the subject device from the predicate device, this submission leverages performance and electrical testing provided in previous submission.
Meanwhile, self-select and usability testing (OTC Study) was completed in 24 subjects to evaluate device human factors and label comprehension. These study tests demonstrate that the subject device and its labeling can meet 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.
#### 9 Biocompatibility
All the modified device materials which come in direct contact with the patient skin are biocompatible and identical to the materials used in the predicate device manufacturing. No biocompatibility test report is provided in this submission.
#### 10 Clinical performance
Clinical performance is not deemed necessary.
#### 11 Comparison with predicate device
Compare with predicate device (Hand-held IPL device (IPL Home Use Hair Removal Device) K221214), the subject device is same in design principle, functions, material and the applicable standards. And the intended use of subject device is same to Reference device K222432. The differences between subject device and predicate devices do not raise any new questions of safety or effectiveness.
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| Item | Subject Device | Predicate Device | Reference Device |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Shenzhen IONKA Medical Technology Co., Ltd. | Shenzhen IONKA Medical Technology Co., Ltd. | Hunan Guangye Biotechnology<br>Co., Ltd. |
| K number | K230739 | K221214 | K222432 |
| Product Name | Hand-held IPL device (IPL Home Use Hair Removal<br>Device)<br>Model: FZ-608, FZ-608G, FZ-100, FZ-200 | Hand-held IPL device (IPL Home Use Hair Removal<br>Device)<br>Model: FZ-608, FZ-608G, FZ-100, FZ-200 | IPL Hair Removal Device<br>Model: KCA423, KCA437, KCA439 |
| Regulation &<br>Classification | Classification Name: Laser surgical instrument for use in<br>general and plastic surgery and in dermatology<br>Review Panel: General & Plastic Surgery<br>Product Code: OHT<br>Regulation Number: 878.4810<br>Regulation Class: 2 | Classification Name: Powered Light Based Non-Laser<br>Surgical Instrument With Thermal Effect<br>Review Panel: General & Plastic Surgery<br>Product Code: ONF<br>Regulation Number: 878.4810<br>Regulation Class: 2 | Classification Name: Laser surgical<br>instrument for use in general and<br>plastic surgery and in dermatology<br>Review Panel: General & Plastic<br>Surgery<br>Product Code: OHT<br>Regulation Number: 878.4810<br>Regulation Class: 2 |
| Indications for<br>Use | IPL Home Use Hair Removal Device is indicated for the<br>removal of unwanted hair. The device is also indicated<br>for the permanent reduction in hair regrowth, defined as<br>the long-term, stable reduction in the number of hairs<br>regrowing when measured at 6, 9 and 12 months after<br>the completion of a treatment regime. | IPL home use hair removal device is indicated for patient<br>removal of unwanted hair by using a selective<br>photothermal treatment under the direction of a<br>physician, after training by a healthcare professional.<br>The IPL home use hair removal device is also intended<br>for permanent reduction in unwanted hair. Permanent<br>hair reduction is defined as the long-term stable<br>reduction in the number of hairs regrowing when<br>measured at 6. 9. and 12 months after the completion of<br>a treatment regimen.<br>The device is used for adults with Fitzpatrick skin types I | IPL Hair Removal Device is<br>indicated for the removal of<br>unwanted hair. The device is also<br>indicated for the permanent<br>reduction in hair regrowth, defined<br>as the long-term, stable reduction in<br>the number of hairs regrowing<br>when measured at 6, 9 and 12<br>months after the completion of a<br>treatment regime. |
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| Item | Subject Device | Predicate Device | Reference Device | | |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--------------|
| | OTC Use | - IV. | OTC Use | | |
| Source Energy | Supplied by external adapter | Prescription Use<br>Supplied by external adapter | Supplied by external adapter | | |
| Device Type | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | | |
| Wavelength<br>(nm) | 510nm~1200nm | 510nm~1200nm | 475-1200nm | | |
| Spot Size | 3 cm2 | 3 cm2 | 3 cm2 | | |
| | FZ-608, FZ-608G:<br>Level 1: 4.16J<br>Level 2: 4.36J<br>Level 3: 5.1J<br>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: 10.0J | FZ-100:<br>Level 1: 5.7J<br>Level 2: 6.5J<br>Level 3: 8.06J<br>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 | FZ-200:<br>Level 1: 4.6J<br>Level 2: 5.7J<br>Level 3: 6.63J<br>Level 4: 8.66J<br>Level 5: 11.3J<br>Level 6: 13.5J | | |
| Energy output<br>range | | FZ-608, FZ-608G:<br>Level 1: 4.16J<br>Level 2: 4.36J<br>Level 3: 5.1J<br>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 | FZ-100:<br>Level 1: 5.7J<br>Level 2: 6.5J<br>Level 3: 8.06J<br>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 | FZ-200:<br>Level 1: 4.6J<br>Level 2: 5.7J<br>Level 3: 6.63J<br>Level 4: 8.66J<br>Level 5: 11.3J<br>Level 6: 13.5J | 7.35J to 15J |
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| Max. energy<br>output density | FZ-608, FZ-608G: 3.33 J/cm² | | 5 J/cm² | | |
| | FZ-100: 5.43 J/cm² | FZ-100: 5.43 J/cm² | | | |
| | FZ-200: 4.5 J/cm² | | | | |
| Pulse duration | 0.5~0.8 ms | | 7~10ms | | |
| Energy medium | Xenon Arc Flashlamp | | Xenon Arc Flashlamp | | |
| Pulsing Control | Finger switch | | Finger switch | | |
| Delivery device | Direct illumination to tissue | | Direct illumination to tissue | | |
Report by Shenzhen IONKA Medical Technology Co., Ltd.
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| Item | Subject Device | Predicate Device | Reference Device |
|-----------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Skin proximity<br>sensor | Sensor fixed in device and can be moved to treatment part | Sensor fixed in device and can be moved to treatment part | Sensor fixed in device and can be<br>moved to treatment part |
| Number of<br>output channel | One channel | One channel | One channel |
| Energy output<br>level | FZ-608, FZ-608G: 9 levels<br>FZ-100: 9 levels<br>FZ-200: 6 levels | FZ-608, FZ-608G: 9 levels<br>FZ-100: 9 levels<br>FZ-200: 6 levels | 7 levels |
| Software<br>Control? | Yes | Yes | Yes |
| Structure<br>design | Handheld | Handheld | Handheld |
| Weight | FZ-608, FZ-608G: 1.515kg<br>FZ-100: 1.515kg<br>FZ-200: 1.1kg | FZ-608, FZ-608G: 1.515kg<br>FZ-100: 1.515kg<br>FZ-200: 1.1kg | KCA423: 223g<br>KCA437: 255g<br>KCA439: 235g |
| Dimensions | FZ-608, FZ-608G: 98*147*60(mm)<br>FZ-100: 198*71*44(mm)<br>FZ-200: 216*68*52(mm) | FZ-608, FZ-608G: 98*147*60(mm)<br>FZ-100: 198*71*44(mm)<br>FZ-200: 216*68*52(mm) | KCA423: 164.82*76.4*40mm<br>KCA437: 162*76.7*43.2mm<br>KCA439: 162.2*77.9*42.4mm |
| Electrical<br>safety, EMC | AAMI/ANSI ES60601-1<br>IEC 60601-1-11<br>IEC 60601-2-83<br>IEC 60601-1-2 | AAMI/ANSI ES60601-1<br>IEC 60601-1-11<br>IEC 60601-2-83<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-1-11<br>IEC 60601-2-83<br>IEC 60601-1-2 |
| Biocompatibility | ISO10993-5<br>ISO10993-10 | ISO10993-5<br>ISO10993-10 | ISO10993-5<br>ISO10993-10 |
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Although the indication for use of subject device is different to predicate device K221214, but it is only to simplify the statement of the legally existing predicate device and remove the prescription use statement, which is not involved with technical specifications. The revised indication for use of subject device in this submission also had been covered by the indication for use of the legally existing predicate device; which is same to Reference device K222432. And the subject device had been verify by usability study for its OTC use. So the difference does not affect the safety and effectiveness.
#### 12 Summary Prepared Date
7 March. 2023
