IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG
Device Facts
| Record ID | K230549 |
|---|---|
| Device Name | IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG |
| Applicant | Shenzhen Xiazhifeng Electronic Co., Ltd. |
| Product Code | OHT · General, Plastic Surgery |
| Decision Date | Apr 25, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The IPL Hair Removal Device is an over-the-counter device, intended for removal of unwanted body and/or facial hair.
Device Story
Personal light-based hair reduction device; utilizes IPL technology via Xenon flashlamp. Device consists of main unit and external power adapter; includes sixteen models varying by appearance, enclosure color, and presence of skin cooling function. Operated by user in home environment; device delivers optical radiation to skin via non-removable lamp head. User triggers pulses via finger switch; device provides 5 intensity levels. Output parameters (energy density, pulse duration) are controlled by internal microprocessor. Intended to reduce unwanted hair; benefits include convenient, at-home hair removal. Healthcare providers do not operate device; output is visual/physical effect on hair follicles.
Clinical Evidence
Bench testing only. No clinical data provided. Testing included biocompatibility (ISO 10993-5, -10, -23), electrical safety/EMC (IEC 60601-1, -1-2, -1-11, -2-83), photobiological eye safety (IEC 62471), and software validation. Performance testing verified output energy density and pulse duration against specifications.
Technological Characteristics
IPL hair removal device; Xenon flashlamp source; 510-1100nm wavelength; 1.1-3.0 J/cm² energy density; 5.0±2.0 ms pulse duration. Powered by 100-240V AC external adapter. Biocompatible materials per ISO 10993. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83, IEC 62471. Microprocessor-controlled; 5 intensity levels; finger switch activation. No sterilization required.
Indications for Use
Indicated for removal of unwanted body and/or facial hair in patients with Fitzpatrick Skin Types I-V.
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 HAIR REMOVAL HANDSET (IPL-666) (K220669)
- Home use hair removal device (T4, T5, T8, T4-01, T5-01, T8-01, T7) (K220248)
Related Devices
- K231613 — Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. · Zhuzhou Goldenhot Medical Technology Co., Ltd. · Jul 31, 2023
- K253304 — IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C) · Dongguan Lide Electric Appliance Co., Ltd. · Nov 25, 2025
- K232845 — IPL Cooling Hair Removal Device · Shenzhen Siken 3D Technology Development Co., Ltd. · Nov 14, 2023
- K232846 — Light Based Hair Removal Device · Shenzhen Meik Beauty Industry Co., Ltd. · Dec 7, 2023
- K230060 — Light Based Hair Removal Device GP592 · Shenzhen Gsd Tech Co., Ltd. · Mar 3, 2023
Submission Summary (Full Text)
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April 25, 2023
Shenzhen Xiazhifeng Electronic Co., Ltd. % Tracy Che Registration engineer Feiving Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Oianhai Road Shenzhen, Guangdong 518052 China
Re: K230549
Trade/Device Name: IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG 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: February 28, 2023 Received: February 28, 2023
Dear Tracy Che:
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 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) K230549
#### Device Name
IPL Hair Removal Device
Model(s): FY-B505AG, FY-B505AG, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AG, FY-B509AG, FY-B509BL, FY-B509BG
#### Indications for Use (Describe)
The IPL Hair Removal Device is an over-the-counter device, intended for removal of unwanted body and/or facial hair.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary
### "510(k) Summary" as required by 21 CFR Part 807.92.
#### I. Submitter
Shenzhen Xiazhifeng Electronic Co., Ltd.
201, No. 39, Longfeng Road, Xinsheng Community, Longgang Street, Longgang District, Shenzhen, Guangdong, China Post code: 518116 Tel.: +86 0755-28992929 James Li General Manager Tel: +86 13760395988 Email: 2850977367@qq.com Date of preparation: 2023-4-6
#### II. Device
Name of Device: IPL Hair Removal Device Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG Common or Usual Name: Light Based Over-The-Counter Hair Removal Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: OHT Regulation Number: 21 CFR 878.4810
### III. Predicate Devices
Primary predicate device:
| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
|---------------------------------------------|---------------------------------------|---------------|---------------|
| Shenzhen Junbobeauty<br>Technology Co., Ltd | IPL HAIR REMOVAL<br>HANDSET (IPL-666) | K220669 | May 16, 2022 |
Predicate device:
| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
|-------------------------------|--------------------------------------------------------------------|---------------|---------------|
| Shenzhen Mareal Tech Co., Ltd | Home use hair removal device (T4, T5, T8, T4-01, T5-01, T8-01, T7) | K220248 | July 1, 2022 |
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# IV. Device Description
The IPL Hair Removal Device is a personal, light-based, hair reduction device. The device provides hair reduction using IPL technology. Of which, the Device includes FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AG, FY-B509AG, FY-B509BL, FY-B509BG sixteen models. All have adopted the same structure design, consisting of IPL Hair Removal Device main unit and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is powered from power adapter via an external power. The difference of all models is mainly appearance, cooling function and enclosure color, letter A in the model name means with skin cooling function, letter B means without skin cooling function, letter L means the enclosure color is light green, letter G is deep green, which do not affect the intended use.
# V. Indications for Use
The IPL Hair Removal Device is an over-the-counter device, intended for removal of unwanted body and/or facial hair.
### VI. Comparison of Technological Characteristics With the Predicate Device
The IPL Hair Removal Device has the same intended use, mode of action and similar operational characteristics as the predicate device. Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate devices for its intended use. Therefore, the IPL Hair Removal Device may be found substantially equivalent to its predicate devices.
IPL Hair Removal Device is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance:
| Comparison<br>Elements | Subject Device | Primary Predicate<br>Device | Predicate Device | Remark |
|------------------------|--------------------------------------------------------------------------------------------------|------------------------------------------------|------------------------------------------------------------------------------|--------|
| 510(k)<br>Number | Pending | K220669 | K220248 | / |
| Trade name | IPL Hair Removal<br>Device<br>(FY-B505AL, FY-B505AG,<br>B505BL,<br>B505BG,<br>B507AL,<br>B507AG) | IPL<br>HAIR<br>REMOVAL<br>HANDSET<br>(IPL-666) | Home use hair removal<br>device<br>(T4, T5, T8, T4-01, T5-<br>01, T8-01, T7) | / |
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| | B507BL,<br>FY-<br>B507BG,<br>FY-<br>B508AL,<br>FY-<br>B508AG,<br>FY-<br>B508BL,<br>FY-<br>B508BG,<br>FY-<br>B509AL,<br>FY-<br>B509AG,<br>FY-<br>B509BL,<br>FY-<br>B509BG) | | | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Manufacturer | Shenzhen Xiazhifeng<br>Electronic Co., Ltd. | Shenzhen Junbobeauty<br>Technology Co., Ltd | Shenzhen Mareal Tech<br>Co., Ltd | / |
| Regulation<br>number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Product code | OHT | OHT | OHT | Same |
| Device<br>classification | Class II | Class II | Class II | Same |
| Indication for<br>use/ Intended<br>use | The IPL Hair<br>Removal Device is<br>an over-the-counter<br>device, intended for<br>removal of<br>unwanted body<br>and/or facial hair. | IPL HAIR<br>REMOVAL<br>HANDSET is an<br>over-the-counter<br>device intended for<br>removal of unwanted<br>body and/or facial<br>hair. | The Home use hair<br>removal device is an<br>over-the-counter device<br>intended for removal of<br>unwanted hair such as<br>but not limited to small<br>areas such as underarm<br>and facial hair below<br>the chin line and large<br>areas such as legs, in<br>patients with<br>Fitzpatrick Skin<br>Phototypes I-V. | Same |
| Prescription<br>or OTC | OTC | OTC | OTC | Same |
| Applicable<br>skin | Fitzpatrick Skin<br>Types I-V | Fitzpatrick Skin<br>Phototypes I-V | Fitzpatrick skin types I<br>- V | Same |
| Treatment<br>area | Small areas such as<br>underarm, bikini<br>line.<br>Large areas such as<br>legs, arms. | Used on facial hair<br>below the chin line,<br>arms, legs,<br>underarms, bikini<br>line. | Small areas such as<br>underarm and facial<br>hair below the chin<br>line.<br>Large areas such as<br>legs. | Similar |
| Device design | | | | |
| Source energy | Supplied by<br>external adapter | Supplied by external<br>adapter | Supplied by external<br>adapter | Same |
| Power supply | 100-240V<br>AC<br>Input<br>12V3A DC Output | 100~240V AC Input<br>12V3A DC Output | Unknown | Same |
| Dimension | 36*61.5*183 mm | 124*83*48.5mm | Unknown | Different |
| Sterilization | Not required | Not required | Not required | Same |
| Output specification | | | | |
| Light source | Intense<br>Pulsed<br>Light | Intense Pulsed Light | Intense Pulsed Light | Same |
| Energy<br>medium | Xenon Flashlamp | Xenon Quartz Tube | Xenon Arc Flashlamp | Similar |
| Wavelength<br>range | 510-1100nm | 470-1100nm | 530-1100nm | Similar |
| Energy<br>density | 1.1 ~ 3.0 J/cm² | 1.3-2.49 J/cm² | 2.0~4.3 J/cm² | Similar |
| Output energy | 4.0 J~10.8 J | Level 1: 3.92J<br>Level 2: 4.72J<br>Level 3: 5.62J<br>Level 4: 6.49J<br>Level 5: 7.48J | 7.8-15.39 J | Similar |
| Spot size | 3.6 cm² | 3 cm² | 3.5 cm², 3.9 cm² | Similar |
| Pulse duration | 5.0±2.0 ms | 11.5-15 ms | 5.0~9.6 ms | Similar |
| Pulsing<br>control | Finger switch | Finger switch | Finger switch | Same |
| Delivery<br>device | Direct illumination<br>to tissue | Direct<br>illumination<br>to tissue | Direct illumination<br>to<br>tissue | Same |
| Output<br>intensity level | 5 Levels | 5 levels | 5 levels | Same |
| Software/<br>Firmware/<br>Microprocess<br>or Control? | Yes | Yes | Yes | Same |
| Additional features | | | | |
| Electrical<br>safety | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-2-83 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-2-83 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-6<br>IEC 60601-1-11<br>IEC 60601-2-57<br>IEC 60601-2-83 | Same |
| Eye safety | IEC 62471 | IEC 62471 | IEC 62471 | Same |
| Biocompatibil<br>ity | ISO 10993-5<br>ISO 10993-10<br>ISO 10993-23 | ISO 10993-5<br>ISO 10993-10 | ISO 10993-5<br>ISO 10993-10 | Same |
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# VII.Performance Data
The following performance data were provided in support of the substantial equivalence determination.
#### 1) Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the IPL Hair Removal Device was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on September 4, 2020", as recognized by FDA. The following testing was performed to, and passed, including:
- > ISO 10993-5:2009. Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
- > ISO 10993-10:2021, Biological evaluation of medical devices -Part 10: Tests for skin sensitization
- > ISO 10993-23:2021, Biological evaluation of medical devices –Part 23: Tests for skin irritation
#### 2) Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, as per the following standards:
- > IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
- > ANSI AAMI ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- > IEC 60601-1-11 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 60601-2-83 Medical electrical equipment Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
### 3) Eye Safety
- > IEC 62471 Photobiological safety of lamps and lamp systems
#### 4) Software Verification and Validation
Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
#### 5) Usability
The product usability has been evaluated and verified according to the following FDA guidance
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> Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016
#### 6) Performance Testing
> Product output energy density has been tested and verified according to product specification and the test results have confirmed that this parameter complied with specification requirement.
> Product pulse duration has been tested and verified according to product specification and the test results have confirmed that this parameter complied with specification requirement.
#### VIII. Conclusions
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device IPL Hair Removal Device is as safe, as effective, and performs as well as the legally marketed predicate devices.
