The IPL Hair Removal 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 Xenon Lamp to emit light and 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. The IPL Hair Removal includes two models, W-1095 and W-1098. The two models are the same in intended use, working principle, the main differences are appearance and output parameters.

AI/ML Overview

The provided text is a 510(k) Summary for an IPL Hair Removal device. It does not describe an AI/ML powered device, but rather a physical medical device. Therefore, much of the requested information regarding acceptance criteria and study data for an AI/ML model (e.g., sample size for test set, ground truth experts, MRMC study, training set details) is not applicable or present in this document.

However, I can extract the relevant information regarding the device's "performance" and the non-clinical tests performed to demonstrate safety and effectiveness, which serve as the acceptance criteria from a regulatory perspective for this type of device.

Here's a breakdown of the available information based on your request, with an emphasis on what is present and what is not:

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

The document does not present "acceptance criteria" in the typical sense of a target metric for an AI model (e.g., AUC > X, sensitivity > Y). Instead, the "acceptance criteria" are implied by the compliance with recognized standards for medical devices and the demonstrated substantial equivalence to predicate devices. The "reported device performance" is primarily in terms of meeting these technical and safety standards.

Acceptance Criteria Category	Specific Criteria (Implied by Compliance)	Reported Device Performance (as stated)
Intended Use Equivalence	Device is intended for removal of unwanted body and/or facial hair, similar to predicates.	IPL Hair Removal is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Technological Characteristics Equivalence	Similar technology (IPL), power source, light source, wavelength range, energy density, spot size, pulse duration, pulsing control, delivery device, output channels, output intensity levels, skin sensor, software/firmware, skin-contacting components.	Similar: Regulation number, Product code, Class, Indications for use, Prescription/OTC, Applicable skin phototypes (I-V), Power source, Power supply, Light source, Energy medium, Wavelength range (470nm ~ 1100nm vs 510nm ~ 1100nm), Pulsing control (Finger switch), Delivery device (Direct illumination), Number of output channels (One channel), Skin sensor (Sensor fixed in device). Similar but different values: Energy density (W-1095: 1.67~~4.46 J/cm², W-1098: 1.16~~2.79 J/cm² vs. Predicates: 1.3-4.5 J/cm²), Spot size (W-1095: 2.69cm², W-1098: 4.3cm² vs. Predicates: 2.0-4.5cm²), Pulse duration (4-13ms vs. Predicates: 3-15ms), Output intensity levels (W-1095: 5 levels, W-1098: 3 levels vs. Predicates: 5 levels). Different: Dimensions, Weight, Materials of skin-contacting components (ABS, PS vs Plastic, metal, ABS, PC, Aluminium alloy).
Electrical Safety	Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83.	The device complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83.
Photobiological Safety	Compliance with IEC 62471.	The device complies with IEC 62471.
Biocompatibility	Compliance with ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization).	All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements.
Software Verification & Validation	Compliance with FDA guidance "Guidance for Pre Market Submissions and for Software Contained in Medical Devices."	Software verification and validation test performed according to FDA guidance.
Usability Evaluation	Compliance with FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices."	Usability evaluation performed according to FDA guidance.

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

This information is not provided in the document. For a physical device like this, "test set" and "data provenance" as described for an AI/ML model are not typically relevant. The testing is based on engineering validation and adherence to safety standards rather than a clinical dataset for algorithmic performance.

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 applicable/provided. There is no "ground truth" in the diagnostic sense for this type of device, as it's not performing a diagnostic task where expert interpretation is needed to label data.

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

This information is not applicable/provided. Adjudication methods are relevant for resolving discrepancies in expert labeling of ground truth data, which is not the context here.

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 information is not applicable/provided. An MRMC study is specific to evaluating the impact of AI on human reader performance in diagnostic tasks. This device is not an AI-assisted diagnostic tool.

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

This information is not applicable/provided. This is a physical device, not an algorithm.

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

This information is not applicable/provided. As explained, there is no "ground truth" of this nature for a hair removal device. The "ground truth" for regulatory clearance is that the device is safe and effective when used as intended, demonstrated by meeting engineering standards, biocompatibility, and substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" as understood in the context of machine learning.

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

This information is not applicable/provided. There is no "training set" or "ground truth" for it in this context.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services-USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

September 14, 2023

Shenzhen Wochuan Electronic Co., Ltd % Tracy Che 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: K232124

Trade/Device Name: IPL Hair Removal, Model: W-1095, W-1098 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 12, 2023 Received: July 17, 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	Digitally signed byJianting Wang -S
Wang -S	Date: 2023.09.1416:11:07 -04'00'

For Tanisha Hithe, MS. MHS 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) K232124

Device Name IPL Hair Removal, Model: W-1095, W-1098

Indications for Use (Describe)

IPL Hair Removal 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 K232124

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 Wochuan Electronic Co., Ltd
Address:	6th Floor Building No.357 3rd Area A Huayuan Xingye 1 road,Fenghuang Community, Fuyong Street, Baoan District, Shenzhen,Guangdong China
Contact person:	Rebecca Jiang
Phone number:	+86 13823355685
Fax number:	/
Email:	rebecca@szwoc.com
Date of summary prepared:	2023-07-12

(2) Reason for the submission

New device, there were no prior submissions for the device.

(3) Proprietary name of the device

Trade name/model:	IPL Hair Removal, Model: W-1095, W-1098
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

(4) Predicate and reference devices

Predicate devices A

	Primary predicate device	Predicate device
Sponsor	ShenzhenJunbobeautyTechnology Co., Ltd.	Shenzhen Bosidin TechnologyCo.,Ltd.
Device Name and Model	IPL HAIR REMOVALHANDSETModel: IPL-666	IPL Home Use Hair RemovalDeviceModel(s): D-1128, D-1103,D-1119, D-1129, D-1130
510(k) Number	K220669	K192432
Product Code	OHT	OHT

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Regulation Number	21 CFR 878.4810	21 CFR 878.4810
Regulation Class	II	II

> Reference device

Sponsor	Glan Electronics Co., Ltd.
Device Name and Model	IPL Hair Removal, Model: OBT-02
510(k) Number	K213041
Product Code	OHT
Regulation Number	21 CFR 878.4810
Regulation Class	II

(5) Description/ Design of device:

(6) Indications for use:

IPL Hair Removal 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 Hair Removal(Model: W-1095)	ABS+PS	Surface-contactingdevice: Intact skin	Less than 24 hours
IPL Hair Removal(Model: W-1098)	ABS	Surface-contactingdevice: Intact skin	Less than 24 hours

(7) Materials

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

(8) Technological characteristics and substantial equivalence:

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Item	Subject device	Primary predicatedevice	Predicate device	Reference device	Remark
Trade name	IPL Hair Removal,Model W-1095,W-1098	IPL HAIR REMOVALHANDSETModel: IPL-666	IPL Home Use HairRemoval DeviceModel(s): D-1128,D-1103, D-1119,D-1129, D-1130	IPL Hair Removal,Model: OBT-02	/
510 (k)number	Applying	K220669	K192432	K213041	/
Manufacturer	Shenzhen WochuanElectronic Co., Ltd	Shenzhen JunbobeautyTechnology Co., Ltd.	Shenzhen BosidinTechnology Co., Ltd.	Glan ElectronicsCo., Ltd.	/
Regulationnumber	21CFR 878.4810	21CFR 878.4810	21CFR 878.4810	21CFR 878.4810	Same
Product code	OHT	OHT	OHT	OHT	Same
Class	II	II	II	II	Same
Indicationsforuse/Intended use	IPL Hair Removal isan over-the-counterdevice intendedforremoval of unwantedbodyand/orfacialhair.	IPL HAIR REMOVALHANDSET is an over-the-counterdeviceintended for removal ofunwanted body and/orfacial hair.	IPL Home Use HairRemoval Device is anover-the-counterdevice intendedforremoval of unwantedbody and/or facial hair.	The IPL HairRemoval DeviceOBT-02 Versionis indicated for theremoval ofunwanted hair. Thedevice is alsoindicated for thepermanentreduction in hairregrowth, definedas the long-term,stable reduction inthe number of hairsre-growing whenmeasured at 6, 9and 12 monthsafter thecompletion of atreatment regime.The device is usedfor adults.	Same
Prescriptionor OTC	OTC	OTC	OTC	OTC	Same
Applicable	FitzpatrickSkin	FitzpatrickSkin	FitzpatrickSkin	Unknown	Same
skin	Phototypes I-V	Phototypes I-V	Phototypes I-V		Similar
Treatmentarea	Multiple hair removalareas, including smallareas (e.g. armpit,bikini lines) and largeareas (e.g. arms, legs).	The device is designedfor use on the legs,underarms,bikini line, chest,stomach, back, armsand on the face belowthe cheekbones.	Removal of unwantedbody hair such as butnot limited to smallareas such as underarmand facial hair belowthe chin line and largeareas such as legs.	Unknown
Device design
Power source	An external powersupply	An external powersupply	Supplied by externalpower adapter	Supplied byexternal adapter	Same
Power supply	100~240V AC InputDC 12V 3A Output	100~240V AC Input12V3A DC Output	Input:100-240V50/60Hz 1.0-0.5AOutput: DC12V 3A	100-240 V AC	Same
Productcompositions	IPL Hair Removalmain device andpower adapter	IPL Hair RemovalHandset and poweradapter	IPL host, lampcartridge and poweradapter	IPL device andpower supply	Similar
Structuredesign	Handheld	Handheld	Handheld	Handheld	Same
Dimension	W-1095:1636037mmW-1098:170.568.543mm	1248348.5mm	218 x 144 x 60mm	1507545mm(HWD)	Different
Weight	W-1095:~223.5gW-1098:256.92g	186g	355g	220g	Different
Sterilization	Not required	Not required	Not required	Not required	Same
Output specification
Light source	Intense Pulsed Light	Intense Pulsed Light	Intense Pulsed Light	Intense PulsedLight	Same
Energymedium	Xenon Arc flashlamp	Xenon Quartz Tube	Xenon lamp	Xenon ArcFlashlamp	Same
Wavelengthrange (nm)	470nm ~1100nm	470nm ~1100nm	Regular window: 510~ 1100nmFilter window: 600 ~1100mm	510nm~1100nm	Same
Energydensity(J/cm²)	W-1095:1.67~~4.46J/cm²W-1098:1.16~~2.79J/cm²	1.3-2.49J/cm²	2.0~~4.0J/cm²(applicable formodel D-1128,D-1119, D-1129,D-1130)2.5~~4.5J/cm²(Applicable for modelD-1103)	1.5-4.0J/cm2	Similar
Spotsize	W-1095: 2.69cm²	3cm²	Regular window:	3.0cm²	Similar
(Size oftreatmentwindow)(cm²)	W-1098: 4.3cm²		$4.5cm^2$ , $2.0cm^2$ ,$3.0cm^2$Filter window: 2.5cm²
Pulseduration	4-13ms	11.5-15ms	7.5-14ms	3ms	Similar
Pulsingcontrol	Finger switch	Finger switch	Finger switch	Finger switch	Same
Deliverydevice	Direct illumination totissue	Direct illumination totissue	Direct illumination totissue	Direct illuminationto tissue	Same
Number ofoutputchannels	One channel	One channel	One channel	One channel	Same
Outputintensitylevel	W-1095: 5 levelsW-1098: 3 levels	5 levels	5 levels	5 levels	Similar
Skin sensor	Sensor fixed in deviceand can be moved totreatment part	Sensor fixed in handsetand can be moved totreatment part	Sensor fixed in deviceand can be moved totreatment part	Sensor fixed indevice and can bemoved to treatmentpart	Same
Software/Firmware/MicroprocessorControl?	Yes	Yes	Yes	Yes	Same
Additional features
Skin-contactingcomponents	Enclosure and lightoutlet	Plastic enclosure andtreatment window	Plastic enclosure andtreatment window	Enclosure andtreatment window	Same
Materials ofskin-contactingcomponents	ABS, PS	Plastic, metal	ABS, PC, Aluminiumalloy	Unknown	Different
Biocompatibility	All user directlycontacting materialsare compliance withISO10993-5 andISO10993-10requirements.	All user directlycontacting materialsare compliance withISO10993-5 andISO10993-10requirements.	All user directlycontacting materialsare compliance withISO10993-5 andISO10993-10requirements.	All user directlycontactingmaterials arecompliance withISO10993-5 andISO10993-10requirements.	Same
Electricalsafety	IEC60601-1-2IEC60601-1IEC60601-1-11IEC60601-2-83	IEC60601-1-2IEC60601-1IEC60601-1-11IEC60601-2-83	IEC60601-1-2IEC60601-1IEC60601-1-11IEC60601-2-57	IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57	Same
Photobiological safety	IEC62471	IEC62471	IEC62471	Unknown	Same

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Shenzhen Wochuan Electronic Co., Ltd
510(k)s – Section 8. 510 (k) Summary

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(9) Non-clinical studies and tests performed:

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

A IEC 60601-1, Medical electrical equipment - Part 1: General requirements for 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 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, it complies with the following standards.

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

We have also conducted:

A Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
A Usability evaluation according to the requirements of the FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016"

(10) Conclusion

Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device IPL Hair Removal is as safe, as effective, and performs as well as the legally marketed predicate devices and reference 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.