← Product Code [OHT](/productcode/OHT) · K260594

# IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM) (K260594)

_Shenzhen Xiazhifeng Electronic Co., Ltd. · OHT · May 20, 2026 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K260594

## Device Facts

- **Applicant:** Shenzhen Xiazhifeng Electronic Co., Ltd.
- **Product Code:** [OHT](/productcode/OHT.md)
- **Decision Date:** May 20, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4810
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic

## Indications for Use

IPL 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

Over-the-counter, home-use IPL hair removal device; utilizes Xenon Arc lamp to emit light pulses; intended for unwanted hair reduction on arms, legs, underarms, and bikini line. Device features skin contact sensor to prevent pulse emission unless in full contact with skin; includes integrated cooling functions (standard or Sapphire freezing point) to manage treatment area temperature. Operated by user via finger switch; powered by external adapter. Output energy ranges 4.0J-10.8J; wavelength 510-1200nm. Device provides non-invasive hair growth reduction without cutting or pulling. Clinical benefit includes long-term, stable reduction in hair regrowth.

## Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-5, -10), electrical safety/EMC (IEC 60601-1, -1-2, -1-11, -2-83), photobiological eye safety (IEC 62471), software verification/validation, and usability engineering per FDA guidance.

## Technological Characteristics

IPL-based hair removal; Xenon Arc lamp source; 510-1200nm wavelength; 1.2-3.1 J/cm² energy density; 3.0-3.6cm² spot size. Features skin contact sensor, finger switch activation, and integrated cooling (standard or Sapphire). Powered by 100-240V AC adapter. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83, and IEC 62471. Biocompatibility per ISO 10993-5/10.

## Regulatory 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 Device Model: BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06B, BHRL-07, BHRL-08, BHRL-10, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22 ([K243036](/device/K243036.md))

## Reference Devices

- IPL Hair Removal Device Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108 ([K230097](/device/K230097.md))

## Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

May 20, 2026

Shenzhen Xiazhifeng Electronic Co., Ltd.
% Candice Qiu
Registration Specialist
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90
Qianhai Rd.
Shenzhen, Guangdong 518052
China

Re: K260594

Trade/Device Name: IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)

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 12, 2026
Received: February 23, 2026

Dear Candice Qiu:

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K260594 - Candice Qiu
Page 2

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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

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K260594 - Candice Qiu
Page 3

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,

TANISHA L. HITHE -S
Digitally signed by
TANISHA L. HITHE -S
Date: 2026.05.20 23:51:03
-04'00"

Tanisha Hithe
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  |   |   |
| --- | --- | --- |
|  Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K260594 | ?  |
|  Please provide the device trade name(s). |   | ?  |
|  IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)  |   |   |
|  Please provide your Indications for Use below. |   | ?  |
|  IPL 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.  |   |   |
|  Please select the types of uses (select one or both, as applicable). | ☐ Prescription Use (21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) | ?  |

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Shenzhen Xiazhifeng Electronic Co., Ltd. 510(k)s-510(k) Summary

# K260594 - 510(k) Summary

"510(k) Summary" as required by 21 CFR Part 807.92. Feb 11, 2026

## I. Submitter

Shenzhen Xiazhifeng Electronic Co., Ltd.
4th Floor, Building A2, No. 2, Yanhe Road, Xinsheng Community, Longgang Sub-district,
Longgang District, Shenzhen, Guangdong, China, 518116.
James Li
General Manager
Tel: +86 13760395988
Email: 2850977367@qq.com

## II. Device

Name of Device: IPL Hair Removal Device
Model(s): FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM.
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 Device and Reference Device

Predicate device:

|  Manufacturer | Predicate Device | 510(k) Number | Approval Date  |
| --- | --- | --- | --- |
|  Bestway Plastic And Metal Products Ltd. | IPL Hair Removal Device Model: BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06B, BHRL-07, BHRL-08, BHRL-10, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, | K243036 | June 6, 2025  |

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Shenzhen Xiazhifeng Electronic Co., Ltd. 510(k)s-510(k) Summary

|  Manufacturer | Predicate Device | 510(k) Number | Approval Date  |
| --- | --- | --- | --- |
|   | BHRL-20, BHRL-21, BHRL-22 |  |   |

**Reference device:**

|  Manufacturer | Reference Device | 510(k) Number | Approval Date  |
| --- | --- | --- | --- |
|  Shenzhen Technology Co., Ltd. | IPL Hair Removal Device Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108 | K230097 | April 6, 2023  |

## IV. Device Description

IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed twenty-four models with the same IPL technology for hair removal, which is model FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM. The device works below the skin’s surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.

The device is only powered by the external power adapter and its IPL emission activation is by finger switch.

The IPL Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.6cm² (Model FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B511G, FL-B511P, FL-B511M) and 3.0cm² (Model FL-B510G, FL-B510P, FL-B510M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM) that is suitable for hair removal areas, such as arms, legs, underarm, bikini line.

The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the Freezing point cooling function (Only suitable for Model FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM) and Sapphire Freezing point cooling function (Model: FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM) which will be activated throughout the whole hair removal process to cool down the treatment area’s temperature and provide the user with a better using experience.

Page 2 of 7

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Shenzhen Xiazhifeng Electronic Co., Ltd. 510(k)s-510(k) Summary

## V. Indications for Use

IPL 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.

## 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 device and reference device do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device and reference device for its intended use. Therefore, the IPL Hair Removal Device may be found substantially equivalent to its predicate device and reference device.

IPL Hair Removal Device is compared with the following Predicate Device and Reference Device in terms of intended use, design, material, specifications, and performance:

|  Comparison Elements | Subject Device | Predicate Device | Reference Device | Remark  |
| --- | --- | --- | --- | --- |
|  510(k) Number | Pending | K243036 | K230097 | /  |
|  Trade name | IPL Hair Removal Device Model: FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM. | IPL Hair Removal Device Model: BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22 | IPL Hair Removal Device Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108 | /  |
|  Manufacturer | Shenzhen Xiazhifeng Electronic Co., Ltd. | Bestway Plastic And Metal Products Ltd. | Shenzhen BSX Technology Electronics Co., Ltd. | /  |
|  Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same  |

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Shenzhen Xiazhifeng Electronic Co., Ltd.
510(k)s-510(k) Summary

|  Comparison Elements | Subject Device | Predicate Device | Reference Device | Remark  |
| --- | --- | --- | --- | --- |
|  number |  |  |  |   |
|  Product code | OHT | OHT | OHT | Same  |
|  Device classification | Class II | Class II | Class II | Same  |
|  Indication for use/ Intended use | IPL 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. | IPL 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. | The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair. | Same  |
|  Prescription or OTC | OTC | OTC | OTC | Same  |
|  Applicable skin | Fitzpatrick skin types I-V | Fitzpatrick skin types I-V | Fitzpatrick Skin Types I-V | Same  |
|  Dimension | FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM: 61.5(W)*36(H)*183(L)mm FL-B510G, FL-B510P, FL-B510M: 63(W)*36(H)*171(L)mm FL-B511G, FL-B511P, FL-B511M: 61(W)*35(H)*183(L)mm FL-B512AG, FL-B512AP, | BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-07, BHRL-08, BHRL-09, BHRL-10: 80*180*170mm BHRL-05, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17: 70*170*40mm BHRL-06, BHRL- | 190x70x45mm | Difference  |

Page 4 of 7

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Shenzhen Xiazhifeng Electronic Co., Ltd.
510(k)s-510(k) Summary

|  Comparison Elements | Subject Device | Predicate Device | Reference Device | Remark  |
| --- | --- | --- | --- | --- |
|   | FL-B512AM: 64(W)*40(H)*187(L)mm FL-B513AG, FL-B513AP, FL-B513AM: 65(W)*38(H)*185(L)mm | 06B, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22: 60*180*30mm |  |   |
|  Power supply | 100-240V, 50/60Hz, 1A | 100-240V, 50/60Hz, 0.8AMax | 100-240V, 50/60Hz | Same  |
|  Sterilization | Not required | Not required | Not required | Same  |
|  Light source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Same  |
|  Energy medium | Xenon Arc lamp | Xenon Arc lamp | Xenon Arc lamp | Same  |
|  Wavelength range | 510-1200 | 510-1200±15nm | 470nm-1200nm | Similar  |
|  Energy density | FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AL, FL-B509AM, FL-B511G, FL-B511P, FL-B511M: 1.2-3.0J/cm² FL-B510G, FL-B510P, FL-B510M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM: 1.8-3.1J/cm² | 1.2-4.1 J/cm² | Max 5.0 J/cm² | Similar  |
|  Output energy | 4.0J-10.8J | 4.5 ~ 10J (±20%) | Pure mode: 5~10J (±20%) Armpit mode: 6~10J (±20%) Body mode: 6.5~11J (±20%) Bikini mode: 8~12.5J (±20%) | Similar  |
|  Spot size | FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B511G, FL-B511P, FL-B511M: 3.6cm² | Model BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-07, BHRL-08, BHRL-09, BHRL-10: 3.6±0.25cm² Model BHRL-05, | 3.0cm²± 0.5cm² | Similar  |

Page 5 of 7

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Shenzhen Xiazhifeng Electronic Co., Ltd.
510(k)s-510(k) Summary

|  Comparison Elements | Subject Device | Predicate Device | Reference Device | Remark  |
| --- | --- | --- | --- | --- |
|   | FL-B510G, FL-B510P, FL-B510M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM: 3.0cm² | BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-06, BHRL-06B, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22: 2.7±0.25cm² |  |   |
|  Pulse duration | 6.0±2.0ms | 6.4±2.0ms | 4-10ms | Similar  |
|  Pulsing control | Finger switch | Finger switch | Finger switch | Same  |
|  Output intensity level | FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM: 9 levels FL-B510G, FL-B510P, FL-B510M, FL-B513AG, FL-B513AP, FL-B513AM: 5 levels | 5 Levels | 5 Levels | Different  |
|  Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | Same  |
|  Electrical safety | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-83 | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-83 | ANSI AAMI ES60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-83 | Same  |
|  Eye safety | IEC 62471 | IEC 62471 | IEC 62471 | Same  |
|  Biocompatibility | ISO 10993-5 ISO 10993-10 | ISO 10993-5 ISO 10993-10 | ISO 10993-5 ISO 10993-10 | Same  |

VII.Performance Data

Page 6 of 7

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Shenzhen Xiazhifeng Electronic Co., Ltd. 510(k)s-510(k) Summary

The following performance data were provided in support of the substantial equivalence determination.

## 1) Biocompatibility Evaluation

- 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 recommended by FDA.

## 2) Electrical Safety and EMC

Electrical safety and EMC testing was performed to, and passed, as per the following standards:

- IEC 60601-1-2: 2020 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance –Collateral standard: electromagnetic compatibility.
- IEC 60601-1: 2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-11: 2020 Medical electrical equipment - Part 1-11: 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: 2020 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: 2006 Photobiological safety of lamps and lamp systems

## 4) Software Verification and Validation

Software documentation consistent with *Basic Documentation 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

- Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016.

## 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.

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**Source:** [https://fda.innolitics.com/device/K260594](https://fda.innolitics.com/device/K260594)

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