The IPL Hair removal is a personal, light-based, hair reduction device intended to be sold overthe-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. The device consists of IPL main body and power adapter two parts, and treatment window located in the main body which is the source of optical radiation, namely a Xenon Arc flashlamp; and the device is power from power adapter via an external power.

The IPL Hair removal includes V501, V201, V301-s, and V401 four models. Their intended use, performance, circuit principle, structure design and operation are basically identical, with the differences contains the appearance of the product , the size of PCB board and LCD display contents; and these differences do not affect or change the intended use of the device.

AI/ML Overview

This document is a 510(k) premarket notification for an "IPL Hair removal" device. It demonstrates substantial equivalence to existing predicate devices, focusing on technical specifications and safety testing, rather than clinical performance data typical for AI/ML-based diagnostic devices.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not applicable to this submission, as it is a device for hair removal and not an AI or diagnostic tool. The document focuses on showing the new device is as safe and effective as previously cleared over-the-counter IPL hair removal devices.

Here's an attempt to address the points based on the provided document, with clear indications of where information is not applicable (N/A) due to the nature of the device and submission:

Device: IPL Hair Removal (Models V501, V201, V301-s, V401)

Type of Submission: 510(k) Premarket Notification (K203510)

Device Classification: Class II, Product Code OHT (Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology)

Intended Use: Over-the-counter device intended for removal of unwanted body hair and/or facial hair.

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

For this type of device, "acceptance criteria" are primarily related to safety and technical specifications, demonstrating substantial equivalence to predicate devices, rather than performance metrics like sensitivity/specificity for a diagnostic AI. The document outlines comparisons to predicate devices in terms of technical characteristics and adherence to safety standards.

Acceptance Criteria (General)	Reported Device Performance (as per document)
Functional Equivalence to Predicate Devices	"The IPL Hair removal has the same intended use, mode of action and similar operational characteristics as the predicate devices." (Page 4, Section VI)
Safety - Biocompatibility	Passed ISO 10993-5:2009/(R)2014 (In Vitro Cytotoxicity) and ISO 10993-10:2010/(R)2014 (Irritation and Skin Sensitization) for body-contacting components. (Page 6, Section 1)
Safety - Electrical & Eye Safety	Passed IEC 60601-1-2 (Electromagnetic Compatibility), IEC 60601-1 (General Safety), IEC 60601-1-11 (Home Healthcare Environment), IEC 60601-2-57 (Non-laser source equipment for therapeutic/cosmetic use), and IEC 62471 (Photobiological safety). (Page 6, Sections 2 & 3)
Software Verification & Validation	Software documentation consistent with moderate level of concern was submitted. System validation testing "demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels." (Page 6, Section 4)
Performance (general)	"Performance data supports that the device is safe and as effective as the predicate device for its intended use." (Page 4, Section VI) This is a summary statement, not specific quantitative performance data for hair removal efficacy itself (e.g., percentage of hair reduction over time), which is commonly accepted for OTC hair removal devices via comparison to predicates. The document implies that the device's technical specifications (wavelength, energy density, spot size, pulse duration) are comparable enough to the predicates to infer similar performance.

2. Sample size used for the test set and the data provenance

Sample Size:
- For biocompatibility, electrical safety, and eye safety, the "samples" are the device components or the device itself undergoing standard tests. The document doesn't specify a "sample size" in terms of human subjects or a dataset for performance evaluation in the way an AI/diagnostic device would.
- No clinical "test set" in the context of diagnostic accuracy for AI devices is mentioned or required for this type of 510(k) submission.
Data Provenance: N/A for a clinical test set. The data presented is from in-house engineering and safety testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. This information is not relevant to this 510(k) submission. This device is not an AI/diagnostic tool requiring expert-established ground truth for performance evaluation. Safety and technical compliance are assessed against established standards and predicate devices.

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

N/A. No clinical test set requiring adjudication of ground truth 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

N/A. This device is an over-the-counter physical hair removal device, not an AI-assisted diagnostic tool.

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

N/A. Not an algorithm-based device.

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

N/A. No diagnostic "ground truth" is used for this device. The "truth" for this submission is adherence to recognized safety standards and functional equivalence to legally marketed predicate devices.

8. The sample size for the training set

N/A. This device does not use a "training set" in the context of machine learning or AI development.

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

N/A. Not an AI/ML device.

Summary of the Study Proving Device Meets Acceptance Criteria (based on provided document):

The "study" proving the device meets acceptance criteria for this 510(k) submission is a compilation of engineering tests and comparative analysis rather than a clinical trial or AI performance study:

Technical Comparison: The applicant demonstrated that the IPL Hair removal device has the "same intended use, mode of action and similar operational characteristics" as its identified predicate devices (K192432, K161428, K160968). This includes comparing wavelength range, energy medium, energy density, spot size, pulse duration, pulsing control, delivery device, and indications for use.
Biocompatibility Testing: Body-contacting components were tested and passed ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and skin sensitization).
Electrical Safety and Eye Safety Testing: The device was tested against and passed several IEC 60601 series standards for electrical safety, essential performance, and electromagnetic compatibility in both general and home healthcare environments, as well as IEC 62471 for photobiological safety.
Software Verification and Validation: Software documentation meeting "moderate level of concern" was submitted, confirming that software requirements were met and hazards mitigated.

The conclusion is that, based on these performance data, the IPL Hair removal device "was found to have a safety and effectiveness profile that is similar to the predicate devices," thereby establishing substantial equivalence.

Summary

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February 26, 2021

Shenzhen Weikai Technology CO.,LTD % Rain Yip Registered Engineer Feiying Drug & Medical Consulting Technical Service Group Rm2401, ZhenYe International Center, No.3101-90 Qianhai Road, Nanshan District Shenzhen, Guangdong 518000 China

Re: K203510

Trade/Device Name: IPL Hair removal 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: November 11, 2020 Received: November 30, 2020

Dear Rain Yip:

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/cfpm/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,

Purva U. Pandya -S

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) K203510

Device Name IPL Hair removal V501, V201, V301-s, V401

Indications for Use (Describe)

IPL Hair removal is an over-the-counter device intended for removal of unwanted body hair 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

K203510

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

Date: 2020-11-11

I. Submitter

Shenzhen Weikai Technology CO.,LTD Rm.101&201, Bldg.4, Haoer Jiashitai Technology Park, Fengtang Avenue No.164, Heping Community, Fuhai Street, Bao'an District, Shenzhen, Guangdong, China Post code: 518118 Tel.: +86 0755 8337 4619

LI JING General Manager Tel: +86 180 1876 9288 Email: 50917560@qq.com

II. Device

Name of Device: IPL Hair removal Model(s): V501, V201, V301-s, V401 Common or Usual Name: Light Based Over-The-Counter Hair Removal Classification 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

Manufacturer	Predicate Device	510(k) Number	Approval Date
ShenzhenTechnology Co.,Ltd.	Bosidin IPL Home Use Hair RemovalDevice/D-1128	K192432	Nov.8, 2019
Shen Zhen CosBeauty Co.,Ltd	PerfectSmooth/CB-014	K161428	Mar. 23, 2017
CyDen Limited.	iPulse SmoothSkin GoldHair Removal System	K160968	Apr.14, 2016

IV. Device Description

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treatment window located in the main body which is the source of optical radiation, namely a Xenon Arc flashlamp; and the device is power from power adapter via an external power.

V. Indications for Use

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

VI. Comparison of Technological Characteristics With the Predicate Device

The IPL Hair removal has the same intended use, mode of action and similar operational characteristics as the predicate devices. Any minor differences between the subject device and 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 Hair removal may be found substantially equivalent to its predicate device.

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

K192432, "IPL Home Use Hair Removal Device/D-1128", manufactured by "Shenzhen Bosidin Technology Co.,Ltd. " in Guangdong, China
K161428, "PerfectSmooth", manufactured by "Shen Zhen CosBeauty Co., Ltd" in Guangdong, China

Comparison	Subject Device	Predicate Device
Elements		K192432(Primary)	K161428	K160968
K Number	Pending	K192432	K161428	K160968
Trade name	IPL Hair removal	IPL Home UseHair RemovalDevice	PerfectSmooth	iPulseSmoothSkinGold HairRemoval System
Wavelengthrange	530-1200nm	Regular window:510-1100nmFilter window:600-1100nm	≥510nm	510-1100nm
Energymedium	XenonArcFlashlamp	XenonArcFlashlamp	XenonArcFlashlamp	XenonArcFlashlamp
Energy density	3.0~4.0J/cm2	2.0~4.0J/cm2	4.7 J/cm2Max.	3~6 J/cm2
Spot size	3.7cm2	Regular window:	4.5 cm2	3 (3cm by 1cm)
ComparisonElements	Subject Device	Predicate Device
		K192432(Primary)	K161428	K160968
		4.5cm ²; 2.0cm ²Filter window:2.5cm ²
Pulse duration	4~13ms	7.5~14ms	11-13ms	2-10ms
Pulsing control	Finger switch	Finger switch	Finger switch	Finger switch
Delivery device	Direct illuminationto tissue	Directilluminationtissue	Directilluminationtissue	Directilluminationtissue
Indication foruse/Intendeduse	IPL Hair removalis an over-the-counter deviceintended forremoval ofunwanted bodyhair and/or facialhair.	IPL Home UseHair RemovalDevice is anover-the-counterdevice intendedfor removal ofunwanted bodyand/or facial hair.	ThePerfectSmooth isan over-the-counter deviceintended forremoval ofunwanted hairsuch as but notlimited to smallareas such asunderarm andfacial hair belowthe chin line andlarge areas suchas legs.	TheiPulseSmoothSkinGoldHairRemoval Systemis indicated forthe removal ofunwanted hair.TheiPulseSmoothskin Goldis also indicatedfor the permanentreduction in hairregrowth, definedas the long-term,stable reductionin the number ofhairs regrowingwhen measuredat 6, 9 and 12months after thecompletion of atreatment regime.
Location foruse	OTC	OTC	OTC	OTC

K160968, "iPulse SmoothSkin Gold Hair Removal System", manufactured by "CyDen Limited" in Wales, UK

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VII.Performance Data

The following performance data were provided in support of the substantial equivalence determination.

1) Biocompatibility Testing

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The biocompatibility evaluation for the body-contacting components of the IPL Hair removal was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on June 16, 2016", as recognized by FDA. The battery of testing was performed to, and passed, including:

ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices –Par t 5: Tests for In Vitro Cytotoxicity
ISO 10993-10:2010/(R)2014, Biological Evaluation of Medical Devices -Par t 10: Tests for Irritation and Skin Sensitization

2) Electrical Safety and Eye Safety

Electrical safety and Eye safety testing was performed to, and passed, 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
IEC 60601-1 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 60601-2-57 Medical electrical equipment -- Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

3) Eye Safety

IEC 62471 Photobiological safety of lamps and lamp systems

4) Software Verification and Validation

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

Summary

Based on the above performance as documented in this application, IPL Hair removal was found to have a safety and effectiveness profile that is similar to the predicate devices.

VIII. Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, the IPL Hair removal is to be concluded substantial equivalent to its predicate 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.