IPL Hair Removal Device (Model: BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108), is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). 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 (a.c.100~240V 50/60Hz) and its IPL emission activation is by finger switch. It contains a skin sensor to detect appropriate skin contact, if the Light Outlet of the device is not in full contact with the skin, the device cannot trigger a light pulse. The device have six models and these models share the same performance, structure and operation, the only difference is their enclosure color.

AI/ML Overview

The provided document does not contain information about specific acceptance criteria related to clinical performance metrics (e.g., hair reduction percentage, adverse event rates) or a detailed study demonstrating the device meets such criteria. Instead, it focuses on non-clinical studies for safety and functional equivalence to predicate devices.

Therefore, the following information cannot be extracted from the document:

A table of acceptance criteria and the reported device performance regarding hair removal efficacy.
Sample size used for a test set (clinical or performance efficacy).
Data provenance for a clinical test set.
Number of experts used to establish ground truth for a clinical test set and their qualifications.
Adjudication method for a clinical test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
If a standalone (algorithm only) performance study was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a clinical study.
The sample size for the training set (as no AI/algorithm performance study is described).
How the ground truth for the training set was established.

However, the document does describe non-clinical studies conducted to demonstrate substantial equivalence, focusing on safety and technical performance.

Here's a summary of the non-clinical studies and their conclusions as presented:

Acceptance Criteria and Reported Device Performance (Non-Clinical):

The document states that non-clinical tests were conducted to verify that the IPL Hair Removal Device meets all design specifications and complies with various safety standards. While specific numerical acceptance criteria for each test are not explicitly detailed (e.g., current limits, specific temperature ranges), compliance with the listed standards serves as the acceptance criterion for these non-clinical aspects.

Acceptance Criteria (Compliance with Standards)	Reported Device Performance
Biocompatibility:
ISO 10993-5 (In Vitro Cytotoxicity)	Complies
ISO 10993-10 (Irritation & Skin Sensitization)	Complies
Electrical Safety and EMC:
IEC 60601-1-2 (EMC)	Passed
ANSI AAMI ES60601-1 (Basic Safety & Essential P.)	Passed
IEC 60601-1-11 (Home Healthcare Environment)	Passed
IEC 60601-2-83 (Home Light Therapy Equipment)	Passed
Eye Safety:
IEC 62471 (Photobiological Safety)	Complies
Software Verification & Validation:
FDA Guidance: "Software Contained in Medical Devices"	Test according to requirements
Usability:
FDA Guidance: "Human Factors & Usability Engineering"	Evaluated and Verified

Study Details:

The non-clinical studies were conducted to support the conclusion of Substantial Equivalence (SE) to predicate devices. These are laboratory-based tests rather than clinical trials with human subjects for efficacy.

Sample size used for the test set and the data provenance: Not applicable in the context of clinical efficacy; these were non-clinical, laboratory-based tests on the device itself.
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): Not applicable, as ground truth in this context refers to compliance with established technical and safety standards, not clinical diagnoses or outcomes. The tests were performed by a "reliable third-party lab" for biocompatibility.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical compliance testing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No (not an AI/algorithm device in this context).
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For non-clinical tests, the "ground truth" is adherence to the specifications and requirements set forth by the cited international and national standards (e.g., ISO, IEC, ANSI AAMI).
The sample size for the training set: Not applicable, as no AI/machine learning algorithm requiring a training set is described in relation to clinical efficacy.
How the ground truth for the training set was established: Not applicable.

Summary

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April 6, 2023

Shenzhen BSX Technology Electronics Co., Ltd. % Riley Chen 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: K230097

Trade/Device Name: IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108 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: December 28, 2022 Received: January 13, 2023

Dear Riley Chen:

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.

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

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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,

Colin K. Chen -S

for

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)

Device Name IPL Hair Removal Device Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108

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 BSX Technology Electronics Co., Ltd.

Rm101&2/F~4/F, Building No.13, Ailian Industrial Park, Wulian Community, LongGang District, ShenZhen, 518116, GuangDong, P.R. China. Tel .: +86-0755-28719103

Hong Li Regulation Assistant Tel: +86 18133439986 Email: 1013540630@qq.com

II. Device

Name of Device: IPL Hair Removal Device Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108 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

Primary predicate device:

Manufacturer	Predicate Device	510(k) Number	Approval Date
Medical Device Branch ofZhangzhou EasepalIndustrial Co.,Ltd.	IPL Salon Hair ReductionSystem (Model: F60001)	K181568	Sep. 11, 2018

Reference devices:

Manufacturer	Reference Device	510(k) Number	Approval Date
Shenzhen JunbobeautyTechnology Co., Ltd.	IPL HAIR REMOVALHANDSET, Model: IPL-666	K220669	May 16, 2022
Shenzhen LeaflifeTechnology Co., Ltd	Leaf Smooth	K212697	Nov. 19, 2021

IV. Device Description

IPL Hair Removal Device (Model: BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108), is an over-the-counter, home-use and personal device for hair reduction by using

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Intense Pulsed Light (IPL). 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 (a.c.100~240V 50/60Hz) and its IPL emission activation is by finger switch. It contains a skin sensor to detect appropriate skin contact, if the Light Outlet of the device is not in full contact with the skin, the device cannot trigger a light pulse. The device have six models and these models share the same performance, structure and operation, the only difference is their enclosure color.

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. Materials

Component name	Material of Component	Body Contact Category	Contact Duration
IPL Hair Removal Device	ABS	Surface-contacting device: Intact skin	Less than 24 hours

We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to Section 16 "Biocompatibility Discussion".

VII. Comparison of Technological Characteristics With the Predicate Device

The IPL Hair Removal Device has the same intended use as the predicate and reference devices. The technological characteristics such as wavelength, energy density, spot size and pulse duration, are similar to the predicate device and reference devices. Any minor differences between the subject device and the listed predicate device and reference devices 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 devices for its intended use. Therefore, the IPL Hair Removal Device may be found substantially equivalent to its predicate device and reference devices.

ComparisonElements	Subject Device	Predicate Device	Reference Device 1	Reference Device 2	Remark
510(k)Number	Pending	K181568	K220669	K212697	/
Trade name	IPL Hair RemovalDevice	IPL Salon HairReduction System,Model: F60001	IPLHAIRREMOVALHANDSETModel: IPL-666	Leaf Smooth	/
Manufacturer	ShenzhenTechnologyElectronics Co., Ltd.	BSX Medical Device Branchof Zhangzhou EasepalIndustrial Co.,Ltd.	ShenzhenJunbobeautyTechnology Co., Ltd.	Shenzhen LeaflifeTechnology Co., Ltd	/
Regulation	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	Same
ComparisonElements	Subject Device	Predicate Device	Reference Device 1	Reference Device 2	Remark
number
Product code	OHT	OHT	OHT	OHT	Same
Deviceclassification	Class II	Class II	Class II	Class II	Same
Indication foruse/ Intendeduse	The IPL HairRemoval Device isan over-the-counterdevice intended forremoval ofunwanted body and/or facial hair.	The IPL Salon HairReduction System(Model: F60001) is anover the Counter deviceintended for the removalof unwanted bodyand/or facial hair inadults. It is also intendedfor permanent reductionin unwanted hair.Permanent hairreduction is defined asthe long-term stablereduction in the numberof hairs re-growingwhen measured at 6. 9.and 12 months after thecompletion of atreatment regimen.	IPL HAIRREMOVALHANDSET is anover-the-counterdevice intended forremoval of unwantedbody and/or facialhair.	The Leaf Smooth isan over-the-counterdevice intended forremoval ofunwanted bodyand/or facial hair.	Same
Prescriptionor OTC	OTC	OTC	OTC	OTC	Same
Applicableskin	Fitzpatrick SkinTypes I-V	/	Fitzpatrick SkinTypes I-V	/	Same
Device design
Sourceenergy	Supplied by externaladapter	Supplied by externaladapter	Powered by externalpower adapter	Supplied byexternal adapter	Same
Power supply	100-240V, 50/60Hz	100-240V AC; 50/60 Hz	100~240V AC Input12V3A DC Output	/	Same
Dimension	190 x 70 x 45 mm	14369.543mm(HWD)	1248348.5mm	/	Different
Weight	Approx. 225 g	650g	186g	/	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 Pulsed Light	Same
Energymedium	Xenon Arc lamp	Xenon Arc Flashlamp	Xenon Quartz Tube	Xenon ArcFlashlamp	Same
Wavelengthrange	470nm-1200nm	475nm-1200nm	470nm~1100nm	475-1100nm	Similar
ComparisonElements	Subject Device	Predicate Device	Reference Device 1	Reference Device 2	Remark
Energydensity	Max 5.0 J/cm²	Max 5.0 [J/cm²]	1.3~2.49J/cm²	4-6J/cm²	Similar
Spot size	3.0cm² ± 0.5cm²	1.72 cm² or 3.02 cm²	3cm²	3.8cm²	Same
Pulseduration	4-10ms	11-12 ms	11.5-15ms	2-10ms	Similar
Pulsingcontrol	Finger switch	Finger switch	Finger switch	Finger switch	Same
Deliverydevice	Direct illuminationto tissue	Direct illuminationto tissue	Direct illumination totissue	Direct illuminationto tissue	Same
Outputintensity level	5 Levels	5 Levels	5 Levels	6 Levels	Same
Software/Firmware/Microprocessor Control?	Yes	Yes	Yes	Yes	Same
Additional features
Electricalsafety	ANSIAAMIES60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-83	IEC 60601-1IEC 60601-1-2IEC 60601-2-57	IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-83	ANSI/AAMIES60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57	Same
Eye safety	IEC 62471	/	IEC 62471	IEC 62471	Same
Biocompatibility	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	Same

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Non-clinical studies and performance data VIII.

Non-clinical tests were 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 and reference devices. The test results demonstrated that the subject device complies with the following standards:

1) Biocompatibility Testing

The device has been tested for biocompatibility, it complies with the following standards:

ISO 10993-5:2009, Biological Evaluation of Medical Devices -Par t 5: Tests for In Vitro Cytotoxicity
ISO 10993-10:2010, Biological Evaluation of Medical Devices -Par t 10: Tests for Irritation and Skin Sensitization

2) Electrical Safety and EMC

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

5) Usability

The product usability has been evaluated and verified according to the FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices", issued on FEBRUARY 2016.

IX. 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 device and reference 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.