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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for an IPL Hair Removal Device, primarily focusing on demonstrating its substantial equivalence to previously cleared predicate devices rather than providing a detailed study proving its performance against acceptance criteria.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, expert involvement, and ground truth establishment are not present in this document. The document primarily focuses on demonstrating conformance to established safety and electrical standards and comparing specifications with predicate devices.

However, I can extract what is available:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly list "acceptance criteria" for clinical performance. Instead, it refers to equivalence with predicate devices and compliance with various safety and performance standards. The reported performance is implicitly through meeting these standards and having similar specifications to the predicate devices.

Acceptance Criteria (Inferred from regulatory compliance and predicate comparison)	Reported Device Performance
Biocompatibility: No adverse biological reactions from body-contacting components	Passed ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (skin irritation).
Electrical Safety & EMC: Compliance with relevant electrical safety and electromagnetic compatibility standards	Passed IEC 60601-1-2, ANSI AAMI ES60601-1, IEC 60601-1-11, IEC 60601-2-83.
Eye Safety: Compliance with photobiological safety standards	Passed IEC 62471.
Software Verification & Validation: Software meets requirements and hazards are mitigated.	System validation testing demonstrated all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
Usability: Compliance with human factors and usability engineering guidance.	Evaluated and verified according to "Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016".
Product Output Energy Density: Product delivers energy density within specification.	Tested and verified according to product specification; complied with requirement.
Product Pulse Duration: Product delivers pulse duration within specification.	Tested and verified according to product specification; complied with requirement.
Indications for Use: Over-the-counter device, intended for removal of unwanted body and/or facial hair.	Matches predicate devices and is stated as an intended use.
Applicable Skin Types: Fitzpatrick Skin Phototypes I-V.	Matches predicate devices and is stated.
Treatment Area: Small areas such as underarm, bikini line; large areas such as legs, arms.	Similar to predicate devices.
Light Source: Intense Pulsed Light.	Same as predicate devices.
Energy Medium: Xenon Flashlamp (or similar).	Similar to predicate devices (Xenon Quartz Tube, Xenon Arc Flashlamp).
Wavelength Range: 510-1100nm.	Similar to predicate devices (470-1100nm, 530-1100nm).
Energy Density: 1.1 ~ 3.0 J/cm².	Similar to predicate devices (1.3-2.49 J/cm², 2.0~4.3 J/cm²).
Output Energy: 4.0 J~10.8 J.	Similar to predicate devices (various levels from 3.92J-7.48J and 7.8-15.39 J).
Spot Size: 3.6 cm².	Similar to predicate devices (3 cm², 3.5 cm², 3.9 cm²).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details about a clinical test set or sample size for demonstrating hair removal efficacy. The performance data listed (Biocompatibility, Electrical Safety, Eye Safety, Software, Usability, Output energy density, Pulse duration) are primarily in-house or third-party laboratory tests, not human clinical trials with a "test set" in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided text, as the document does not describe a clinical study involving a "test set" requiring expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available in the provided text.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable to a hair removal device. MRMC studies are typically for medical imaging devices where human readers interpret images, sometimes with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable to a physical hair removal device. The device's "performance" is its ability to remove hair, which is a direct physical effect, not an algorithmic interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the technical performance aspects (biocompatibility, electrical safety, etc.), the "ground truth" is defined by the standards themselves and the test results' compliance with these standards. For hair removal efficacy, the document does not describe any specific clinical ground truth or outcomes data. The marketing clearance is based on substantial equivalence to predicate devices, implying similar "hair removal" outcomes without a new clinical study.

8. The sample size for the training set

This information is not applicable as this device does not appear to use machine learning in a way that would require a "training set" for an algorithm.

9. How the ground truth for the training set was established

This information is not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below.

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 JunbobeautyTechnology Co., Ltd	IPL HAIR REMOVALHANDSET (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

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:

ComparisonElements	Subject Device	Primary PredicateDevice	Predicate Device	Remark
510(k)Number	Pending	K220669	K220248	/
Trade name	IPL Hair RemovalDevice(FY-B505AL, FY-B505AG,B505BL,B505BG,B507AL,B507AG)	IPLHAIRREMOVALHANDSET(IPL-666)	Home use hair removaldevice(T4, T5, T8, T4-01, T5-01, T8-01, T7)	/

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	B507BL,FY-B507BG,FY-B508AL,FY-B508AG,FY-B508BL,FY-B508BG,FY-B509AL,FY-B509AG,FY-B509BL,FY-B509BG)
Manufacturer	Shenzhen XiazhifengElectronic Co., Ltd.	Shenzhen JunbobeautyTechnology Co., Ltd	Shenzhen Mareal TechCo., Ltd	/
Regulationnumber	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	Same
Product code	OHT	OHT	OHT	Same
Deviceclassification	Class II	Class II	Class II	Same
Indication foruse/ Intendeduse	The IPL HairRemoval Device isan over-the-counterdevice, intended forremoval ofunwanted bodyand/or facial hair.	IPL HAIRREMOVALHANDSET is anover-the-counterdevice intended forremoval of unwantedbody and/or facialhair.	The Home use hairremoval device is anover-the-counter deviceintended for removal ofunwanted hair such asbut not limited to smallareas such as underarmand facial hair belowthe chin line and largeareas such as legs, inpatients withFitzpatrick SkinPhototypes I-V.	Same
Prescriptionor OTC	OTC	OTC	OTC	Same
Applicableskin	Fitzpatrick SkinTypes I-V	Fitzpatrick SkinPhototypes I-V	Fitzpatrick skin types I- V	Same
Treatmentarea	Small areas such asunderarm, bikiniline.Large areas such aslegs, arms.	Used on facial hairbelow the chin line,arms, legs,underarms, bikiniline.	Small areas such asunderarm and facialhair below the chinline.Large areas such aslegs.	Similar
Device design
Source energy	Supplied byexternal adapter	Supplied by externaladapter	Supplied by externaladapter	Same
Power supply	100-240VACInput12V3A DC Output	100~240V AC Input12V3A DC Output	Unknown	Same
Dimension	3661.5183 mm	1248348.5mm	Unknown	Different
Sterilization	Not required	Not required	Not required	Same
Output specification
Light source	IntensePulsedLight	Intense Pulsed Light	Intense Pulsed Light	Same
Energymedium	Xenon Flashlamp	Xenon Quartz Tube	Xenon Arc Flashlamp	Similar
Wavelengthrange	510-1100nm	470-1100nm	530-1100nm	Similar
Energydensity	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: 3.92JLevel 2: 4.72JLevel 3: 5.62JLevel 4: 6.49JLevel 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
Pulsingcontrol	Finger switch	Finger switch	Finger switch	Same
Deliverydevice	Direct illuminationto tissue	Directilluminationto tissue	Direct illuminationtotissue	Same
Outputintensity level	5 Levels	5 levels	5 levels	Same
Software/Firmware/Microprocessor Control?	Yes	Yes	Yes	Same
Additional features
Electricalsafety	IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-83	IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-83	IEC 60601-1IEC 60601-1-2IEC 60601-1-6IEC 60601-1-11IEC 60601-2-57IEC 60601-2-83	Same
Eye safety	IEC 62471	IEC 62471	IEC 62471	Same
Biocompatibility	ISO 10993-5ISO 10993-10ISO 10993-23	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 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.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.