The IPL 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. It 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 device contains a Xenon Quartz Lamp Tube to emit light and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot trigger a pulse emitting.

The IPL Hair Removal Device includes: AP10, AP20, AP32 four models. Their intended use, performance, structure design and operation, are essential the same for the device models, with main differences being product appearance, display contents, physical product dimension, treatment area (spot size), output energy and power supply.

AI/ML Overview

The provided text is an FDA 510(k) summary for an IPL Hair Removal Device. It details the device's characteristics, comparison to predicate devices, and non-clinical studies performed to demonstrate substantial equivalence. However, this document does not contain information about studies proving the device meets acceptance criteria related to its clinical efficacy (e.g., hair reduction percentage, number of treatments for efficacy). The non-clinical studies focus on electrical safety, photobiological safety, and biocompatibility, as well as software validation, which are all important for safety and performance but do not address the clinical effectiveness of hair removal.

Therefore, for aspects related to the clinical performance criteria (like hair reduction), the information requested in your prompt (1, 2, 3, 4, 5, 6, 7, 8, 9) cannot be extracted from this document as it does not describe clinical trials for efficacy. The document primarily focuses on demonstrating equivalence to predicate devices based on technical characteristics and safety standards.

Here's what can be extracted and what cannot:

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

Cannot be extracted for clinical efficacy: The document does not state clinical acceptance criteria such as a required percentage of hair reduction or number of treatments. Instead, it focuses on non-clinical performance standards.

For non-clinical performance (safety):

Acceptance Criteria (Standard Conformance)	Reported Device Performance
ANSI AAMI ES 60601-1 (Basic Safety and Essential Performance)	Meets standard
IEC 60601-1-2 (Electromagnetic Disturbances)	Meets standard
IEC 60601-1-11 (Home Healthcare Environment)	Meets standard
IEC 60601-2-83 (Home Light Therapy Equipment)	Meets standard
IEC 62471 (Photobiological Safety)	Meets standard
ISO 10993-5 (In Vitro Cytotoxicity)	Meets standard
ISO 10993-10 (Irritation and Skin Sensitization)	Meets standard
FDA Guidance for Pre Market Submissions and for Software Contained in Medical Devices (Software Verification and Validation)	Meets requirements

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

Cannot be extracted for clinical efficacy: Not mentioned as no clinical efficacy study is described.
For non-clinical testing: Sample sizes are not specified for the safety and performance tests (e.g., how many devices were tested for electrical safety). Data provenance is implicitly from the manufacturer or third-party labs contracted by the manufacturer (Shenzhen Yangyi Technology Co., Ltd. in China). These are non-clinical tests, not human 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)

Cannot be extracted: No clinical trial involving expert assessment of outcomes is described. Ground truth for non-clinical tests is established by adherence to documented test procedures and standards.

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

Cannot be extracted: Not applicable as no clinical trial with human assessment is described.

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

Cannot be extracted: Not applicable. This document describes an IPL hair removal device, not an AI-assisted diagnostic device.

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

Cannot be extracted: Not applicable. This refers to the performance of a diagnostic algorithm, not a therapeutic device. The device itself is "standalone" in that it performs the therapy.

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

Cannot be extracted for clinical efficacy: No clinical efficacy data is presented.
For non-clinical testing: Ground truth is established by the specified international and national performance and safety standards (e.g., IEC, ISO, ANSI AAMI ES). Compliance with these standards indicates the "ground truth" of the device's technical safety and performance.

8. The sample size for the training set

Cannot be extracted: No machine learning model is being trained for clinical decision-making or diagnosis. The device has "Software/Firmware/Microprocessor Control? Yes," and "Software verification and validation test" was done, but this refers to the internal operating software, not an AI trained on a large dataset.

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

Cannot be extracted: Not applicable, as no external training set for an AI/ML model for clinical application is mentioned. Ground truth for internal software validation would be derived from functional requirements and test specifications.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 31, 2023

Shenzhen Yangyi Technology., Ltd % Bing Huang Registration engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Qianhai Road Shenzhen, Guangdong 518052 China

Re: K230021

Trade/Device Name: IPL Hair Removal Device, Model(s): AP10, AP20, AP32 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: January 4, 2023 Received: January 4, 2023

Dear Bing Huang:

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) K230021

Device Name

IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32

Indications for Use (Describe)

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

This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.

(1) Applicant information:

510(k) owner's name:	Shenzhen Yangyi Technology Co., Ltd.
Address:	Third Floor South, NO. 201, Building A8, Hua FaIndustrial Area, Fuyuan 1st Road, ZhanCheng Community,Fuhai Street, Bao'an District, Shenzhen, City

Contact person:	Wang Jie
Phone number:	+86 17837655793
Fax number:	/
Email:	971679079@qq.com
Date of summary prepared:	2023-3-27

(2) Proprietary name of the device

Trade name/model:	IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32
Common name:	Light Based Over-The-Counter Hair Removal
Regulation number:	21 CFR 878.4810
Product code:	OHT
Review panel:	General & Plastic Surgery
Regulation class:	Class II

(3) Predicate and reference device

➤ Predicate device
Sponsor	Shenzhen Bosidin Technology Co., Ltd
Device Name and Model	IPL Home Use Hair Removal DeviceModel(s): D-1128, D-1103, D-1119, D-1129, D-1130
510(k) Number	K192432
Product Code	OHT
Regulation Number	21 CFR 878.4810
Regulation Class	II
➤ Reference device
Sponsor	Shenzhen Junbobeauty Technology Co., Ltd
Device Name and Model	IPL HAIR REMOVAL HANDSET,

Model: IPL-666

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Shenzhen Yangyi Technology Co., Ltd. 510(k)s - Section 8. 510 (k) Summary

510(k) Number	K220669
Product Code	OHT
Regulation Number	21 CFR 878.4810
Regulation Class	II

(4) Description/ Design of device:

(5) Indications for use:

IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Componentname	Material of Component	Body Contact Category	Contact Duration
IPL HairRemovalDevice(Enclosureandlight-emittingwindow)	ABS+PC	Surface-contactingdevice: Intact skin	Less than 24 hours

(6) Materials

We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to "Biocompatibility Discussion".

(7) Technological characteristics and substantial equivalence:

Item	Subject device	Predicate device	Reference device	Remark
Trade name				/
	IPL Hair RemovalDeviceModel(s): AP10, AP20, AP30, AP32	IPL Home Use HairRemoval DeviceModel: D-1128, D-1103, D-1119, D-1129,D-1130	IPL HAIR REMOVALHANDSETModel: IPL-666	/
510 (k) number	Applying	K192432	K220669	/
Manufacturer	Shenzhen YangyiTechnology Co., Ltd.	Shenzhen BosidinTechnology Co., Ltd.	Shenzhen JunbobeautyTechnology Co., Ltd.	/
Regulationnumber	21CFR 878.4810	21CFR 878.4810	21CFR 878.4810	Same
Product code	OHT	OHT	OHT	Same
Class	II	II	II	Same
Indications foruse/ Intendeduse	IPL Hair RemovalDevice is an over-the-counterdevice intended for removal ofunwanted body and/orfacial hair.	IPL Home Use HairRemoval Device is anover-the-counterdevice intended forremoval of unwantedbody and/or facialhair.	IPL HAIR REMOVALHANDSET is anover-the-counter deviceintended for removal ofunwanted body and/orfacial hair.	Same
Prescription orOTC	OTC	OTC	OTC	Same
Applicable skin	Fitzpatrick SkinPhototypes I-V	Fitzpatrick SkinPhototypes I-V	Fitzpatrick SkinPhototypes I-V	Same
Treatment area	Used on facial hairbelow the chin line,arms, legs, underarms,bikini line.	Removal of unwantedbody hair such as butnot limited to smallareas such asunderarm and facialhair below the chinline and large areassuch as legs.	Used on facial hairbelow the chin line,arms, legs, underarms,bikini line.	Similar
Device design
Power source	An external powersupply	Supplied by externaladapter	An external powersupply	Same
Power supply	Input: 100~240V ACOutput:AP10: 24V3A DC;AP20, AP30, AP20:12V4A DC	Input: 100-240V50/60Hz 1.0-0.5AOutput: DC12V 3A	100~240V AC Input12V3A DC Output	DifferentNote 1
Productcompositions	IPL host and poweradapter	IPL host, lampcartridge and poweradapter	IPL Hair RemovalHandset and poweradapter	Similar
Structure	Handheld	Handheld	Handheld	Same
design
Dimension	AP10: 20118480mmAP20: 20916178mmAP30: 1666240mmAP32: 1676341mm	D-1128:21811460mmD-1129:20713763mmD-1103:20713763mmD-1119:19814183mmD-1130:21214164 mm	1248348.5mm	DifferentNote 2
Weight	AP10: 451gAP20: 421gAP30: 320gAP32:320g	D-1128: 355gD-1129:340gD-1103:365gD-1119:370gD-1130:340g	186g	DifferentNote 2
Sterilization	Not required	Not required	Not required	Same
Output specification
Light source	Intense Pulsed Light	Intense Pulsed Light	Intense Pulsed Light	Same
Energy medium	Xenon Arc Flashlamp	Xenon Arc Flashlamp	Xenon Quartz Tube	Same
Wavelength range (nm)	530nm~1100nm	Regular window: 510 ~ 1100nmFilter window: 600 ~ 1100nm	470nm~1100nm	SimilarNote 3
Energy density (J/cm²)	Max 4.3J/cm²	2.0~~4.0J/cm²(applicable for model D-1128, D-1119, D-1129, D-1130)2.5~~4.5J/cm²(applicable for model D-1103)	Max 2.49 J/cm²	SimilarNote 3
Spot size (Size of treatment window) (cm²)	3.3 cm², 3.96 cm²,3.63 cm²	Regular window: 4.5cm², 2.0cm², 3.0cm²Filter window: 2.5cm²	3 cm²	SimilarNote 4
Pulse duration	8.8~13.2ms	7.5~14ms	11.5~15ms	SimilarNote 3
Pulsing control	Finger switch	Finger switch	Finger switch	Same
Delivery device	Direct illumination to tissue	Direct illumination to tissue	Direct illumination to tissue	Same
Number of output channels	One channel	One channel	One channel	Same
Output	5	5	5	Similar
intensity level	(applicable for modelAP10, AP30, AP32)9(applicable for modelAP20)			Note 5
Skin sensor	Sensor fixed in host andcan be moved totreatment part	Sensor fixed in deviceand can be moved totreatment part	Sensor fixed in handsetand can be moved totreatment part	Same
Software/Firmware/MicroprocessorControl?	Yes	Yes	Yes	Same
Additional features
Skin-contactingcomponents	Plastic enclosure andlight-emitting window	Plastic enclosure andtreatment window	Plastic enclosure andtreatment window	Same
Biocompatibility	All user directlycontacting materials arecompliance withISO10993-5 andISO10993-10requirements.	All user directlycontacting materialsare compliance withISO10993-5 andISO10993-10requirements.	All user directlycontacting materials arecompliance withISO10993-5 andISO10993-10requirements.	Same
Electricalsafety	IEC60601-1-2IEC60601-1IEC60601-1-11IEC60601-2-83	IEC60601-1-2IEC60601-1IEC60601-1-11IEC60601-2-57	IEC60601-1-2IEC60601-1IEC60601-1-11IEC60601-2-83	Same
Photobiologicalsafety	IEC62471	IEC62471	IEC62471	Same

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Comparison in details:

Note 1:

The power adapter has been tested along with the subject device for electrical safety, so this difference will not raise any safety/effectiveness problems.

Note 2:

Although the appearance, weight and dimensions are different between the subject and predicate device, these differences are insignificant and do not raise any safety/effectiveness problems.

Note 3:

The energy medium are both Xenon lamp, the output specification such as wavelength range, energy density, pulse duration are close to the predicate and reference device's range, these parameters of the subject device can be basically covered by the predicate and reference devices' range, they are very similar. So this difference will not raise any safety/effectiveness problems.

Note 4:

Although there are differences between subject device models spot sizes compared to the predicate device, the energy density and other light output characteristics are sufficiently similar so that the treatment window size differences do not raise safety/effectiveness concerns when the device is used properly.

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Note 5:

The model AP20 has nine different output levels, but the energy density range of this subject device mode is similar to the predicate device range.

(8) Non-clinical studies and tests performed:

Non-clinical testings have been conducted to verify that the IPL Hair Removal Device meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the subject device conforms to the following performance standards:

ANSI AAMI ES 60601-1, Medical electrical equipment Part 1: General requirements for A basic safety and essential performance
A IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-11, Medical electrical equipment Part 1-11: General requirements for basic A 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
IEC 62471, Photobiological safety of lamps and lamp systems >

The device has been tested for biocompatibility for conformance to the following performance standards:

A ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for InVitro Cytotoxicity
ISO 10993-10, Biological Evaluation of Medical Devices Part 10: Tests for Irritation and A Skin Sensitization.

We have also conducted:

Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"

(9) Conclusion

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 device, IPL Home Use Hair Removal Device.

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.