The IPL Home Use Hair Removal Device is the professional IPL in five levels and offers a beauty experience in comfort of your own home as well as has been designed with unique features for simple, relaxed and effective hair removal.

IPL Home Use Hair Removal Device includes D-1199, D-T099, D-T018, D-T003B, D-T003W, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, 1196B, D-1196C, D-1196C, D-1196C1, D-T099K, D-T012, D-T012W sixteen models. All have adopted basically identical structure design, consisting of IPL host and power adapter two parts, which the host is mainly composed of lamp cartridge, display screen, power and/or level button, skin sensor, fan, flash button and DC socket. D-T099K, D-T099KM, D-1196B, D-1196W do not contain the lee-Cooling function. D-1199, D-T018, D-T019, D-T003B, D-T003W, D-T019Y, D-T019Y, D-1196C, D-1196C1 have Ice-Cooling function and only perform the hair removal and cold compress function simultaneously. D-T012W have lce-Cooling function and it is able to perform the hair removal and cold compress function simultaneously or separately.

AI/ML Overview

This is an FDA 510(k) summary for an IPL Home Use Hair Removal Device. The document establishes substantial equivalence to a predicate device, which is the primary mechanism for FDA clearance of Class II devices like this.

Based on the provided text, a formal study proving the device meets specific acceptance criteria for a new AI/algorithm-driven medical device, as typically described in an acceptance criteria table, was not conducted or reported in this 510(k) summary.

This 510(k) focuses on demonstrating that the IPL Home Use Hair Removal Device is substantially equivalent to legally marketed predicate devices, not on proving new clinical performance through a comparative effectiveness study involving AI or human readers. The "Performance Data" section primarily addresses safety (biocompatibility, electrical safety, EMC, eye safety, software V&V) rather than clinical efficacy through human subject testing.

Therefore, many of the specific details requested in the prompt, such as "effect size of how much human readers improve with AI vs without AI assistance" or "sample size for the training set" related to an AI/algorithm, are not applicable to the information provided in this 510(k) summary.

Here's an analysis based on the information available:

Acceptance Criteria and Device Performance (Not Applicable in the context of AI/Algorithm Performance)

Since this is an IPL hair removal device and not an AI/algorithm-driven diagnostic or assistive device in the typical sense for which such a table would be generated, there are no specific AI model performance acceptance criteria or reported metrics like sensitivity, specificity, or AUC. The "acceptance criteria" here are implicitly meeting the safety and performance standards demonstrated by the predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Summary of Testing)
Biocompatibility:
- No cytotoxicity	Passed ISO 10993-5:2009
- No skin sensitization	Passed ISO 10993-10:2021
- No skin irritation	Passed ISO 10993-23:2021
Electrical Safety & EMC:
- Complies with general safety standards	Passed IEC 60601-1
- Complies with EMC standards	Passed IEC 60601-1-2
- Complies with home healthcare environment standards	Passed IEC 60601-11
- Complies with light therapy equipment standards	Passed IEC 60601-2-83
Eye Safety:
- Complies with photobiological safety	Passed IEC 62471
Software V&V:
- Software requirements met; risks mitigated	System validation testing demonstrated compliance
Clinical Efficacy (Non-AI/Algorithm):
- Safe and effective for hair removal, performing as well as predicate device	Clinical performance data (not detailed in summary, implied similar to predicate due to substantial equivalence) supports safety and effectiveness.
- Similar intended use, mode of action, and operational characteristics to predicate.	Confirmed (see comparison table).

Study Details (As applicable from the 510(k) Summary):

Sample sizes used for the test set and the data provenance:
- Test Set: No specific "test set" in the context of an algorithmic performance study for an AI device. The testing outlined (biocompatibility, electrical safety, etc.) is laboratory-based and engineering verification/validation, not a clinical trial with a "test set" of patient data for an algorithm. Clinical performance is demonstrated by the substantial equivalence to the predicate device, which implicitly means its performance for hair removal is considered equivalent without a new clinical study.
- Data Provenance: Not specified for any performance testing, but the company is Shenzhen Beauty Every Moment intelligent electric Co., Ltd. (China). This suggests testing was likely conducted in China or by labs utilized by the manufacturer. The document doesn't mention retrospective or prospective human data collection for efficacy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of an expert-adjudicated ground truth for an AI algorithm in this 510(k) summary.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No such clinical "test set" or adjudication method for an algorithm is described.
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:
- No. An MRMC comparative effectiveness study was not conducted or reported here. This is an IPL hair removal device, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for an AI algorithm. For the function of the device itself, the "ground truth" for "hair removal" would typically be visual assessment of hair reduction, but no such clinical study specific to this submission is detailed. The performance relies on substantial equivalence to the predicate.
The sample size for the training set:
- Not applicable. There is no AI algorithm being trained mentioned in this submission.
How the ground truth for the training set was established:
- Not applicable. There is no AI algorithm being trained mentioned in this submission.

In summary: This 510(k) clearance document for an IPL Home Use Hair Removal Device relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. This means that its safety and performance (including efficacy for hair removal) are considered equivalent based on engineering design, specifications, and device characteristic comparisons, supplemented by standard safety testing (biocompatibility, electrical safety, eye safety, software V&V). It does not involve the type of clinical performance study required for novel AI/algorithm-driven diagnostic or therapeutic devices that directly assist or interpret medical data for human users or make decisions.

Summary

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June 18, 2024

Shenzhen Beauty Every Moment intelligent electric Co., Ltd. % Youshan Gong RA Specialist Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center No. 3101-90, Qianhai Road Shenzhen, Guangdong 518052 China

Re: K240583 Trade/Device Name: IIPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W) 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: Mav 20, 2024 Received: May 20, 2024

Dear Youshan Gong:

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 (the 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 available 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.

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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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product: and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).

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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-devices/deviceadvice-comprehensive-regulatory-assistance/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.

Tanisha L. Digitally signed b Hithe -S 10:37:34 -04'00

Tanisha Hithe 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) K240583

Device Name

IPL Home Use Hair Removal Device (D-1199, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W)

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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K240583 510(k) Summary

"510(k) Summary" as required by 21 CFR Part 807.92.

Date Prepared: 2024-6-14

-Submitter

Shenzhen Beauty Every Moment intelligent electric Co., Ltd. Rm.301, 501, Bldg. 4, Haoer Jiashitai Technology Park, Fengtang Avenue No. 164, Zhancheng Community, Fuhai Street, Bao'an District, Shenzhen, Guangdong, China Post code: 518100 Tel .: +86755 3388 3239

Luo Huajun Certification engineer Tel: +86755 3388 3239 E-mail: 309024340@qq.com

ll. Device

Name of Device: IPL Home Use Hair Removal Device Model(s): D-1199, D-T099, D-T018, D-T003B, D-T003W, D-T019Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W 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 and Reference Device

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➤ Predicate Device

Manufacturer	Predicate Device	510(k)Number	Approval Date
Shenzhen BeautyEveryMomentintelligent electricCo.,Ltd.	IPL Home Use HairRemoval Device, Model(s):D-1150, D-1171, D-1153, D-1155, D-1156, D-1126, D-1178, D-1187	K211185	December 20,2021

➤ Reference Device1

Manufacturer	Reference Device	510(k)Number	Approval Date
Shenzhen IONKAMedical TechnologyCo., Ltd.	Hand-held IPL device (IPLHome Use Hair RemovalDevice), Model: FZ-608,FZ-608G, FZ-100, FZ-200	K230739	May 26, 2023

► Reference Device2

Manufacturer	Reference Device	510(k)Number	Approval Date
Foshan JindiElectric ApplianceCo.,Ltd	PL Home Use HairRemoval Device, Model(s):JD-TM002, JD-TM003,JDTM012, JD-TM016, JD-TM022	K231717	September 6,2023

IV. Device Description

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IPL Home Use Hair Removal Device includes D-1199, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, 1196B, D-1196C, D-1196C, D-1196C1, D-T099K, D-T012, D-T012W sixteen models. All have adopted basically identical structure design, consisting of IPL host and power adapter two parts, which the host is mainly composed of lamp cartridge, display screen, power and/or level button, skin sensor, fan, flash button and DC socket. D-T099K, D-T099KM, D-1196B, D-1196W do not contain the lee-Cooling function. D-1199, D-T018, D-T019, D-T003B, D-T003W, D-T019Y, D-T019Y, D-1196C, D-1196C1 have Ice-Cooling function and only perform the hair removal and cold compress function simultaneously. D-T012W have lce-Cooling function and it is able to perform the hair removal and cold compress function simultaneously or separately.

V. Indications for Use

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

VI. Materials

Model	Contacted Component Name	Materials
D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W	Host of machine (including air outlet,treatment window, air inlet, buttons)	PC, ABS, PC+ABSCrystal, AL

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

VII. Comparison of Technological Characteristics With the Predicate Device

The IPL Home Use Hair Removal Device has the same intended use, mode of action and similar operational characteristics as the predicate device. Any minor differences between 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 device for its intended use. Therefore, the IPL Home Use Hair Removal Device may be found substantially equivalent to its predicate device.

IPL Home Use Hair Removal Device is compared with the following Predicate Devices in terms of intended use, design, material, specifications and performance:

ComparisonElements	Subject device	Predicate Device	Reference Device 1	Reference Device 2
Model	D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-T099K, D-T099KW, D-1196C, D-1196C1, D-1196B, D-1196W, D-T012, D-T012W	D-1150, D-1171, D-1153,D-1155, D-1156, D-1126,D-1178,D-1187	FZ-608, FZ-608G,FZ-100,FZ-200	JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022
510(k)Number	K240583	K211185	K230739	K231717
Tradename	IPL Home Use Hair RemovalDevice	IPL Home Use HairRemoval Device	Hand-held IPLdevice (IPL HomeUse Hair RemovalDevice)	IPL Home Use HairRemoval Device
ComparisonElements	Subject device	Predicate Device	Reference Device 1	Reference Device 2
Manufacturer	Shenzhen Beauty EveryMoment intelligent electricCo.,Ltd.	Shenzhen BeautyEveryMoment intelligentelectric Co.,Ltd.	Shenzhen IONKAMedical TechnologyCo., Ltd.	Foshan Jindi ElectricAppliance Co.,Ltd
Regulationnumber	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810
Productcode	OHT	OHT	OHT	OHT
Deviceclassification	Class II	Class II	Class II	Class II
Indicationfor use/Intendeduse	IPL Home Use Hair RemovalDevice is an over-the-counterdevice intended for removalof unwanted body and/orfacial hair.	IPL Home Use HairRemoval Device is anover-the-counter deviceintended for removal ofunwanted body and/orfacial hair.	IPL Home Use HairRemoval Device isindicated for theremoval ofunwanted hair. Thedevice is alsoindicatedfor the permanentreduction in hairregrowth, definedasthe long-term,stable reduction inthe number of hairsregrowing whenmeasured at 6, 9and 12 months after	IPL Home Use HairRemoval Device isindicated for the removalof unwanted hair. Thedevice is also indicated forthepermanent reduction inhair regrowth, defined asthe long-term, stablereduction in the numberof hairs regrowing whenmeasured at 6, 9 and 12months after thecompletion of a treatmentregime.
ComparisonElements	Subject device	Predicate Device	Reference Device 1	Reference Device 2
			the completion of atreatment regime.
Prescription or OTC	OTC	OTC	OTC	OTC
Wavelength range	530-1100nm,590-1100nm	Regular window: 530-1100nm,590-1100nmFilter window: 600-1100nm	510nm~1200nm	JD-TM002,JD-TM003:550-1100nmJD-TM012,JD-TM016:600-1100nmJD-TM022:640-1100nm
Energydensity	2-6.18 J/cm2(Error: +/-20%)	2.0~4.5 J/cm²	FZ-608, FZ-608G:3.33 J/cm2FZ-100: 5.43 J/cm2FZ-200: 4.5 J/cm2	JD-TM002,JDTM003,JD-TM012,JD-TM016: 2-5 J/cm²JD-TM022:2-6 J/cm²
Spot size	3.4 cm²	Regular window:3.8cm², 3.6cm²,3.0cm², 1.0cm², 2.0cm²,1.9cm²,1.8cm²,Filter window: 3.0cm²,2.0cm²	3.0cm²	JD-TM002,JDTM003,JD-TM012:3 cm²JD-TM016:3.3 cm²JD-TM022: 4 cm²
Pulseduration	0.725-1.283ms (+/-20%)	7.5~12ms	0.5~0.8 ms	8-12ms

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VIII.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 subject device was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Bioloqical Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process", 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, the following standards:

IEC 60601-1 Medical electrical equipment –Part 1: General requirements for basic safety and essential performance ▲
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 60601-11 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

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Software documentation consistent with basic documentation level was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and have been mitigated to acceptable risk levels.

IX. Conclusions

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