The IPL HAIR REMOVAL HANDSET 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.

AI/ML Overview

The provided document is a 510(k) summary for the IPL HAIR REMOVAL HANDSET, Model: IPL-666. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria or extensive clinical study outcomes.

Therefore, much of the requested information regarding specific acceptance criteria, device performance, sample sizes, expert involvement, efficacy studies (MRMC or standalone), and training set details for AI/algorithm performance cannot be extracted from this document. This type of document typically focuses on technical and safety equivalence to a legally marketed predicate.

However, I can provide the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria for device performance related to hair removal efficacy. Instead, it relies on demonstrating substantial equivalence to a predicate device based on technical characteristics and safety testing.

Acceptance Criteria (Not Explicitly Stated for Performance)	Reported Device Performance (Summary of Technical Characteristics)
Safety and Functionality Standards:
Electrical Safety (IEC 60601-1, -1-2, -1-11)	Device complies with these standards.
Particular Requirements for Home Light Therapy (IEC 60601-2-83)	Device complies with this standard.
Photobiological Safety (IEC 62471)	Device complies with this standard.
Biocompatibility (ISO 10993-5, -10)	Skin-contacting materials comply with these standards.
Software Verification & Validation	Performed according to FDA guidance.
Technical Design (Compared to Predicate):
Light source: Intense Pulsed Light	Same as predicate.
Energy medium: Xenon Quartz Tube / Xenon lamp	Similar to predicate (Xenon Arc Flashlamp / Xenon lamp).
Wavelength range (nm): 470nm ~1100nm	Similar to predicate (475nm~~1200nm for predicate, 510~~1100nm for reference).
Energy density (J/cm²): Max 2.49J/cm²	Similar to predicate (Max 5J/cm² for predicate, 2.0-4.5 J/cm² for reference).
Spot size (cm²): 3cm²	Same as predicate (1.72 cm² or 3.02 cm² for predicate, various for reference).
Pulse duration: 11.5-15ms	Similar to predicate (11-12ms for predicate, 7.5-14ms for reference).
Output intensity levels: 5 levels	Same as predicate.
Skin sensor: Present	Same as predicate.
Intended use: Removal of unwanted body and/or facial hair	Same as predicate.
Applicable skin phototypes: Fitzpatrick I-V	Same as reference device. Unknown for predicate.

2. Sample size used for the test set and the data provenance
The document does not detail a clinical test set with human subjects for performance evaluation. The "tests" mentioned are non-clinical (electrical safety, biocompatibility, software V&V) and do not involve a "test set" in the context of clinical performance data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document does not describe a clinical test set requiring expert-established ground truth for efficacy.

4. Adjudication method for the test set
Not applicable, as no clinical test set for efficacy is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence based on technical specifications and safety testing, not direct clinical performance comparison with human readers or AI.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is an IPL hair removal handset, which is a physical medical device, not an AI/algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The type of ground truth used
Not applicable, as no clinical performance study requiring ground truth for efficacy is described. The "ground truth" in this context would generally relate to measured hair reduction, which is not presented here.

8. The sample size for the training set
Not applicable, as this is a physical device and not an AI/algorithm-based product requiring a training set.

9. How the ground truth for the training set was established
Not applicable, as this is a physical device and not an AI/algorithm-based product requiring a training set.

Summary

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May 16, 2022

Shenzhen Junbobeauty Technology Co., Ltd. % Tracy Che Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Oianhai Road Shenzhen, Guangdong 518052 China

Re: K220669

Trade/Device Name: IPL HAIR REMOVAL HANDSET, Model: IPL-666 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 25, 2022 Received: March 7, 2022

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 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 mediation-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.

Purva Pandya 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) K220669

Device Name IPL HAIR REMOVAL HANDSET, Model: IPL-666

Indications for Use (Describe)

IPL HAIR REMOVAL HANDSET 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)
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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 Junbobeauty Technology Co., Ltd.
Address:	#522, Jinyuan Business Building A, Xixiang Blvd 300, Bao'an District, Shenzhen
Contact person:	Jian Zhan
Phone number:	+86 17665318870
Fax number:	/
Email:	779182481@qq.com
Date of summary prepared:	2022-2-25

(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 HANDSET, Model: IPL-666
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 device

> Predicate device

Sponsor	Medical Device Branch of Zhangzhou Easepal IndustrialCo.,Ltd.
Device Name and Model	IPL Salon Hair Reduction System, Model: F60001
510(k) Number	K181568
Product Code	OHT
Regulation Number	21 CFR 878.4810
Regulation Class	II
> Reference device
Sponsor	Shenzhen Bosidin Technology Co. Ltd.
Device Name and Model	IPL Home Use Hair Removal Device

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K220669

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

Model(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

(5) Description/ Design of device:

The IPL HAIR REMOVAL HANDSET includes only one model IPL-666.

(6) Indications for use:

IPL HAIR REMOVAL HANDSET is an over-the-counter device intended for removal of unwanted body and/or facial hair.

(7) Materials

Componentname	Material of Component	Body Contact Category	Contact Duration
IPL HAIRREMOVALHANDSET(Enclosureand flashwindow)	Plastic, metal	Surface-contactingdevice: Intact skin	Less than 24 hours

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:

Item	Subject device	Predicate device	Reference device	Remark
Trade name	IPL HAIR REMOVALHANDSETModel: IPL-666	IPL Salon HairReduction System,Model: F60001	IPL Home Use HairRemoval DeviceModel(s): D-1128,	/

510 (k) number	Applying	K181568	D-1103, D-1119,D-1129, D-1130K192432	/
Manufacturer	Shenzhen JunbobeautyTechnology Co., Ltd.	Medical DeviceBranch of ZhangzhouEasepal IndustrialCo., Ltd.	Shenzhen BosidinTechnology 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 REMOVALHANDSET is an over-the-counter deviceintended for removal ofunwanted body and/orfacial hair.	The IPL Salon HairReduction System(Model: F60001) is anover the Counterdevice intended forthe removal ofunwanted body and/orfacial hair in adults. Itis also intended forpermanent reductionin unwanted hair.Permanent hairreduction is defined asthe long-term stablereduction in thenumber of hairsre-growing whenmeasured at 6. 9. and12 months after thecompletion of atreatment regimen.	IPL Home Use HairRemoval Device 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	Unknown	Fitzpatrick SkinPhototypes I-V	Same
Treatment area	Used on facial hairbelow the chin line,arms, legs, underarms,bikini line.	The device isdesigned for use onthe 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.	Similar
Device design
Power source	An external power supply	Supplied by external adapter	Supplied by external power adapter	Same
Power supply	100~240V AC Input 12V3A DC Output	100-240 V AC; 50/60 Hz	Input: 100-240V 50/60Hz 1.0-0.5AOutput: DC12V 3A	DifferentNote 1
Product compositions	IPL Hair Removal Handset and power adapter	Device includes a treatment window head, a facial adaptor and battery charger/ AC cord.	IPL host, lamp cartridge and power adapter	Similar
Structure design	Handheld	Handheld	Handheld	Same
Dimension	1248348.5mm	143 x69.5 x 43mm (HWD)	218 x 144 x 60mm	DifferentNote 2
Weight	186g	650g	355g	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 Quartz Tube	Xenon Arc Flashlamp	Xenon lamp	SimilarNote 3
Wavelength range (nm)	470nm ~1100nm	475nm~1200nm	Regular window: 510 ~ 1100nmFilter window: 600 ~ 1100nm	SimilarNote 3
Energy density (J/cm²)	Max 2.49J/cm²	Max 5J/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)	SimilarNote 3
Spot size (Size of treatment window) (cm²)	3cm²	1.72 cm² or 3.02 cm²	Regular window: 4.5cm², 2.0cm², 3.0cm²Filter window: 2.5cm²	Same
Pulse duration	11.5-15ms	11-12ms	7.5-14ms	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 levels	5 levels	5 levels	Same
intensity level
Skin sensor	Sensor fixed in handsetand can be moved totreatment part	Sensor fixed in deviceand can be moved totreatment part	Sensor fixed in deviceand can be moved totreatment part	Same
Software/Firmware/MicroprocessorControl?	Yes	Yes	Yes	Same
Additional features
Skin-contactingcomponents	Plastic enclosure andtreatment window	IPL Lamp outputwindow	Plastic enclosure andtreatment window	Same
Materials ofskin-contactingcomponents	Plastic, metal	ABS	ABS, PC, Aluminiumalloy	DifferentNote 4
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	IEC 60601-1IEC 60601-1-2IEC60601-2-57	IEC60601-1-2IEC60601-1IEC60601-1-11IEC60601-2-57	Similar
Photobiologicalsafety	IEC62471	Unknown	IEC62471	Same

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K220669

Shenzhen Junbobeauty Technology Co., Ltd.
510(k)s – Section 8. 510 (k) Summary

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

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

Note 4:

Although the "Materials of skin-contacting components" of the subject device and predicate device are not exactly the same, the skin-contacting components of the subject device has been tested and satisfied the standard requirements of ISO 10993-1. So this difference will not raise any safety/ effectiveness problems.

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(9) Non-clinical studies and tests performed:

Non-clinical testings have been conducted to verify that the IPL HAIR REMOVAL HANDSET 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 complies with the following 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
A 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.

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

We have also conducted:

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

(10) Conclusion

Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device IPL HAIR REMOVAL HANDSET is as safe, as effective, and performs as well as the legally marketed predicate device, IPL Salon Hair Reduction System.

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.