IPL Hair Removal

K211174 · Shenzhen Qiaochengli Technology Co., Ltd. · OHT · Sep 1, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K211174
• Device Name: IPL Hair Removal
• Applicant: Shenzhen Qiaochengli Technology Co., Ltd.
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Sep 1, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IPL HAIR REMOVAL Device (Model: TFDA06S) is indicated for the removal of unwanted hair under the direction of a physician, after training by a healthcare professional. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.

Device Story

Portable, AC-powered (100-240V) IPL hair removal device (Model: TFDA06S); uses Xenon arc flashlamp to emit light (470-1200nm) to heat hair roots; finger-switch activated; intended for adult use under physician direction after professional training; non-invasive; reduces hair growth without cutting or pulling; provides permanent hair reduction defined as stable reduction at 6, 9, and 12 months post-treatment; device weight 260g; dimensions 185.4 x 68.5 x 41.4mm.

Clinical Evidence

Bench testing only; no clinical trials performed. Safety and performance verified via electrical safety (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993-5 cytotoxicity, ISO 10993-10 irritation/sensitization).

Technological Characteristics

Xenon arc flashlamp energy source; 470-1200nm wavelength; max fluence 4.83 J/cm²; 3 cm² spot size; 11-12 ms pulse duration; AC powered (100-240V); portable form factor (260g); compliant with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-57.

Indications for Use

Indicated for removal of unwanted hair and permanent reduction in hair regrowth in adults; requires physician direction and 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

• IPL Salon Hair Reduction System (K181568)
• Aimanfun Lumea Comfort (K190820)

Submission Summary (Full Text)

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September 1, 2021

Shenzhen Qiaochengli Technology Co., Ltd. % Jet Li Regulation Manager Guangzhou KEDA Biological Tech Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District GuangZhou, Guangdong China

Re: K211174

Trade/Device Name: IPL Hair Removal 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: July 18, 2021 Received: July 23, 2021

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 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) K211174

Device Name IPL HAIR REMOVAL

#### Indications for Use (Describe)

The IPL HAIR REMOVAL Device (Model: TFDA06S) is indicated for the removal of unwanted hair under the direction of a physician, after training by a healthcare professional. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.

Type of Use (Select one or both, as applicable)

| <div style="display:inline-block;"><span style="text-decoration: overline;">☒</span> Exportation (Part 374.9(a) Statement Required)</div> | <div style="display:inline-block;">□ Solely to Service/Repair (374.3(b))</div> |
|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|

> Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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Sponsor: Shenzhen Qiaochengli Technology Co., Ltd. IPL HAIR REMOVAL, Model: TFDA06S Subject Device: K211174 510(k) number:

#### 510(k) Summary

#### Date of the summary prepared: August 27, 2021

# 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 Qiaochengli Technology Co., Ltd.
- Address: 501-5, rujun building, 105 Zhongxing Road, Ma'antang community, Bantian street, � Longgang District, Shenzhen City, Guangdong Province,China
- Phone: [phone] �
- Fax: [phone] �
- � Contact Person (including title): LiPing Zhou
- � E-mail: [e-mail]

### Application Correspondent:

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

#### Subject Device Information 2.

- IPL HAIR REMOVAL, Model: TFDA06S Trade Name: �
- Powered Light Based Non-Laser Surgical Instrument With � Common Name:
- Thermal Effect
- Laser Surgical Instrument For Use In General And Plastic Classification name: � Surgery And Dermatoloty
- � Review Panel: General & Plastic Surgery
- ONF Product Code: �
- 2 Regulation Class: �
- 878.4810 � Regulation Number:

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## 3. Predicate Device Information

| Sponsor | Medical Device Branch of Zhangzhou<br>Easepal Industrial Co.,Ltd. | Kam Yuen Plastic Products Ltd. |
|----------------------|-------------------------------------------------------------------|--------------------------------|
| Device Name | IPL Salon Hair Reduction System | Aimanfun Lumea Comfort |
| 510(k) Number | K181568 | K190820 |
| Regulation<br>Number | 878.4810 | 878.4810 |
| Regulation Class | 2 | 2 |

### 4. Device Description

IPL HAIR REMOVAL, Model: TFDA06S, a portable device, is a prescription 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. It is a personal Light-Based Hair Removal System. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Emission activation is by finger switch. Device includes IPL DEVICE, Power supply and User manual. It is used AC Powered (100-240 V AC). The weight of the device is 260g, and the size is 185.4 x 68.5 x 41.4mm (H*W*D). The device adopts the international photonic beauty IPL technology. The purpose of the light is to heat the root where the hair grows.

### 5. Indications for Use

The IPL HAIR REMOVAL Device (Model: TFDA06S) is indicated for the removal of unwanted hair under the direction of a physician,after training by a healthcare professional. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.

### 6. Test Summary

### Non clinical testing:

IPL HAIR REMOVAL (Model: TFDA06S) has been evaluated the safety and performance by lab bench testing as following:

- � Electrical safety test according to IEC 60601-1, IEC60601-1-11 and IEC 60601-2-57 standards
- � Electromagnetic compatibility test according to IEC 60601-1-2 standard
- � 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.

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Shenzhen Qiaochengli Technology Co., Ltd. Sponsor: IPL HAIR REMOVAL, Model: TFDA06S Subject Device: 510(k) number: K211174

- � Software verification and validation test according to the requirements of the FDA "Guidance for PreMarket Submissions and for Software Contained in Medical Devices"
Clinical testing: No clinical trial is necessary in the submission.

## 7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, and intended use of IPL HAIR REMOVAL (Model: TFDA06S) is substantially equivalent to the predicate devices quoted above.

The Substantial equivalence decision was based on the following comparison with the predicate devices:

| Elements of<br>Comparison | Subject Device | Predicate Device I<br>(Primary) | Predicate Device (II) | Remark |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Device Name<br>and Model | IPL HAIR REMOVAL,<br>Model: TFDA06S | IPL Salon Hair Reduction<br>System, Model: F60001 | Aimanfun Lumea Comfort<br>(Model: A-2788) | -- |
| 510(k) Number | K211174 | K181568 | K190820 | -- |
| Manufacturer | Shenzhen Qiaochengli<br>Technology Co., Ltd. | Medical Device Branch of<br>Zhangzhou Easepal<br>Industrial Co., Ltd. | Kam Yuen Plastic Products<br>Ltd. | -- |
| Indications for<br>Use | The IPL HAIR REMOVAL<br>Device (Model: TFDA06S)<br>is indicated for the removal<br>of unwanted hair under the<br>direction of a physician,<br>after training by a<br>healthcare professional.<br>The device is also<br>indicated for the permanent<br>reduction in hair regrowth,<br>defined as the long-term,<br>stable reduction in the<br>number of hairs re-growing<br>when measured at 6, 9 and<br>12 months after the<br>completion of a treatment<br>regime. The device is used<br>for adults. | The IPL Salon Hair<br>Reduction System (Model:<br>F60001) is an over the<br>Counter device intended<br>for the removal of<br>unwanted body and/or<br>facial hair in adults. It is<br>also intended for<br>permanent reduction in<br>unwanted hair.<br>Permanent hair reduction<br>is defined as the long-term<br>stable reduction in the<br>number of hairs re-growing<br>when measured at 6. 9.<br>And 12 months after the<br>completion of a treatment<br>regimen. | The Aimanfun Lumea<br>Comfort (Model: A-2788) is<br>indicated for patient<br>removal of unwanted hair<br>by using a selective<br>photothermal treatment<br>under the direction of a<br>physician, after training by<br>a healthcare professional.<br>The Aimanfun Lumea<br>Comfort is also intended<br>for permanent reduction in<br>unwanted hair. Permanent<br>hair reduction is defined as<br>the long-term stable<br>reduction in the number of<br>hairs regrowing when<br>measured at 6. 9. and 12 | Same |
| Elements of<br>Comparison | Subject Device | Predicate Device I<br>(Primary) | Predicate Device (II) | Remark |
| | | | months after the<br>completion of a treatment<br>regimen. | |
| Source Energy | Supplied by external<br>adapter | Supplied by external<br>adapter | Supplied by external<br>adapter | Same |
| 'Use'<br>Classification | Prescription use | OTC | Prescription use | Same |
| Device<br>Classification | Class II | Class II | Class II | Same |
| Device Type | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Same |
| Wavelength (nm) | 470nm~1200nm | 475nm~1200nm | 475~1200nm | Similar |
| Max. Fluence<br>(J/cm²) | Max 4.83 [Joules/cm²] | Max 5.0 [Joules/cm²] | Max 4.5 [Joules/cm²] | Similar |
| Spot Size (cm2) | 3 cm² | 1.72 cm² or 3.02 cm² | 3.0 cm² | Same |
| Pulse duration | 11-12 ms | 11-12 ms | 3 milliseconds | Same |
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Same |
| 60601Complianc<br>e 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 60601-1<br>and IEC 60601-1-2,<br>IEC60601-2-57 | Yes<br>Comply with IEC<br>60601-1 and IEC 60601-1-<br>2,IEC60601-2-57 | Same |
| Weight | 260g | 650g | 200g | Similar |
| Dimensions | 185.4*68.5*41.4 mm<br>(H*W*D) | 143*69.5*43mm(H*W*D) | 138.9*82*47.3mm(H*W*D) | Similar |

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Sponsor: Shenzhen Qiaochengli Technology Co., Ltd. Subject Device: IPL HAIR REMOVAL, Model: TFDA06S 510(k) number: K211174

# Finial Conclusion:

Based on the nonclinical testing conducted, the subject device "IPL HAIR REMOVAL, Model: TFDA06S" is as safe, as effective, and performs as well as the legally marketed predicate devices.