The IPL Home Use Hair Removal Device 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 is by finger switch. The device contains a Xenon lamp 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 emit the treatment light pulses. The device is for single-person use only.

The IPL Home Use Hair Removal Device includes D-1103, D-1119, D-1129 and D-1130 five models. Their intended use, performance, structure design and operation are basically identical, with the differences contains product appearance, LCD display contents, hair removal lamp cartridge's quantity and appearance, as well as lamp tube's placement location; in addition, due to the size of the treatment window in different lamp cartridge, the treatment area (spot size) is different; but these differences do not affect or change the intended use of the device.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the IPL Home Use Hair Removal Device:

Important Note: The provided FDA 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing de novo acceptance criteria and proving them through a clinical study for a novel device. Therefore, much of the requested information (like specific performance metrics for the device's efficacy in hair removal, sample sizes for test/training sets for an AI, and expert ground truthing) is not present in this document. The "performance data" section primarily addresses safety and general performance aspects relative to standards, not direct efficacy claims against predefined criteria.

Description of Acceptance Criteria and Supporting Study

The provided document describes the IPL Home Use Hair Removal Device and its submission for 510(k) clearance by the FDA. The primary objective of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety or effectiveness.

In this context, specific quantitative "acceptance criteria" for hair removal efficacy are not explicitly defined and measured as the primary outcome for this submission. Instead, the "acceptance criteria" are broad: to establish that the device is as safe and effective as the predicate devices, meeting relevant safety standards and showing similar operational characteristics.

The "study" that proves the device meets these (implicit) acceptance criteria is the collection of performance data, biocompatibility testing, electrical safety, eye safety, and software verification and validation activities performed on the device.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document doesn't present explicit quantitative acceptance criteria for hair removal efficacy that the device must meet, nor does it provide specific numerical efficacy performance results in the given tables. Instead, it demonstrates compliance with safety standards and similarity to predicate devices.

Acceptance Criteria (Implicit for 510(k) Equivalence)	Reported Device Performance (Summary from Document)
Biocompatibility: No unreasonable risk from body-contacting components.	- Biocompatibility evaluation conducted per ISO 10993-1. - Passed ISO 10993-5 (In Vitro Cytotoxicity). - Passed ISO 10993-10 (Irritation and Skin Sensitization).
Electrical Safety: Compliance with relevant electrical safety standards.	- Passed IEC 60601-1-2 (EMC). - Passed IEC 60601-1 (Basic safety & essential performance). - Passed IEC 60601-1-11 (Home healthcare use). - Passed IEC 60601-2-57 (Non-laser source equipment for therapeutic/cosmetic use).
Eye Safety: Compliance with standards for photobiological safety.	- Passed IEC 62471 (Photobiological safety of lamps and lamp systems).
Software Functionality: Software operates as intended and hazards are mitigated.	- Software documentation consistent with a moderate level of concern. - System validation testing demonstrated all software requirement specifications are met and hazards mitigated.
Functional Equivalence: Same intended use & similar operational characteristics as predicates.	- Same intended use (removal of unwanted body/facial hair). - Similar mode of action (IPL technology). - Similar operational characteristics (e.g., energy medium, pulsing control, delivery device). - Differences in wavelength, energy density, spot size, and pulse duration are considered minor and not affecting safety or efficacy in achieving substantial equivalence.

2. Sample Size for the Test Set and Data Provenance

This information is not provided in the document. The term "test set" in the context of device performance usually refers to clinical data for efficacy, which is absent as a specific clinical trial outcome here. The performance data presented are primarily safety and engineering tests, not clinical efficacy trials with patient sample sizes.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable/provided. The submission is not based on an AI algorithm where ground truth would be established by experts. The "ground truth" for the safety tests is derived from adhering to international standards and passing defined metrics within those standards.

4. Adjudication Method for the Test Set

This information is not applicable/provided. There is no "test set" in the sense of clinical data requiring expert adjudication for this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This information is not applicable/provided. This is not an AI device or an imaging device where an MRMC study would typically be conducted to compare human reader performance with and without AI assistance.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the safety and general performance data is adherence to recognized international standards (e.g., ISO 10993, IEC 60601 series, IEC 62471). For substantial equivalence, the "ground truth" is also the characteristics and performance of the legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not applicable/provided. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable/provided. As above, no training set for an AI algorithm is involved.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 8, 2019

Shenzhen Bosidin Technology Co. Ltd. % Rain Yip Registered Engineer Feiying Drug & Medical Consulting Technical Service Group Rm. 3005. Area B. Bldg. 1. Southward Ruifeng Business Center Guimiao Road Shenzhen, 518000 CN

Re: K192432

Trade/Device Name: IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 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: August 21, 2019 Received: September 5, 2019

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/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

{1}------------------------------------------------

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,

Purva Pandva 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K192432

Device Name IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

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

Date: 2019-08-21

I. Submitter

Shenzhen Bosidin 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: 518100 Tel.: +86 755 3388 3239

WANG JIAOYAN General Manager Assistant Tel: +86 137 9835 8583 Email: 970207667@qq.com

II. Device

Name of Device: IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 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
Shen Zhen CosBeauty Co.,Ltd	PerfectSmooth/CB-014	K161428	Mar. 23, 2017
Medical Device Branch ofZhangzhou EasepalIndustiral Co.,Ltd.	IPL Salon Hair ReductionSystem/F60001	K181568	Sep. 11, 2018
CyDen Limited.	iPulse SmoothSkin GoldHair Removal System	K160968	Apr.04, 2016

IV. Device Description

The IPL Home Use Hair Removal Device 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

{4}------------------------------------------------

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 is by finger switch. The device contains a Xenon lamp 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 emit the treatment light pulses. The device is for single-person use only.

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. 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 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 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:

K181568, "IPL Salon Hair Reduction System", manufactured by "Medical Device Branch of Zhangzhou Easepal Industiral Co.,Ltd." in Fujian, China
K161428, "PerfectSmooth", manufactured by "Shen CosBeauty Co., Ltd" in Guangdong, China
K160968, "iPulse SmoothSkin Gold Hair Removal System ", manufactured by "CyDen Limited" in Wales, UK

ComparisonElements	Subject Device	Predicate Device
		K161428(Primary)	K181568	K160968
K Number	Pending	K161428	K181568	K160968
Trade name	IPL Home UseHair RemovalDevice	PerfectSmooth	IPL Salon HairReductionSystem	iPulseSmoothSkinGold HairRemoval System
Wavelength	Regular window:	$≥$ 510nm	475-1200nm	510-1100nm
ComparisonElements	Subject Device	Predicate Device
		K161428(Primary)	K181568	K160968
range	510-1100nmFilter window: 600-1100nm
Energymedium	Xenon ArcFlashlamp	Xenon ArcFlashlamp	Xenon ArcFlashlamp	Xenon ArcFlashlamp
Energy density	2.0~~4.0J/cm2(applicable formodel D-1128, D-1119, D-1129, D-1130)2.5~~4.5J/cm2(applicable formodel D-1103)	4.7 J/cm²Max.	5J/cm²Max.	3~6 J/cm²
Spot size	Regular window:4.5cm23.0cm2Filter window:2.0cm22.5cm2	4.5 cm²	Regular window:4.5cm²Facial adapter:1.72cm²	3 (3cm by 1cm)
Pulse duration	7.5~14ms	11-13ms	Unknown	2-10ms
Pulsing control	Finger switch	Finger switch	Finger switch	Finger switch
Delivery device	Direct illuminationto tissue	Directilluminationtissue	Directillumination totissue	Directilluminationtissue
Indicationforuse/Intendeduse	IPL Home UseHair RemovalDevice is an over-the-counter deviceintended forremoval 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.	The IPL SalonHair ReductionSystem (Model:F60001) is anover the Counterdevice intendedfor the removalof unwantedbody and/orfacial hair inadults. It is alsointended forpermanentreduction inunwanted hair.Permanent hairreduction isdefined as the	The iPulseSmoothSkinGold HairRemoval Systemis indicated forthe removal ofunwanted hair.The iPulseSmoothskin Goldis also indicatedfor the permanentreduction in hairregrowth, definedas the long-term,stable reductionin the number ofhairs regrowingwhen measured
ComparisonElements	Subject Device	Predicate Device
		K161428(Primary)	K181568	K160968
			long-term stablereduction in thenumber of hairsre-growing whenmeasured at 6, 9and 12 monthsafter thecompletion of atreatmentregimen.	at 6, 9 and 12months after thecompletion of atreatment regime.
Location foruse	OTC	OTC	OTC	OTC

{5}------------------------------------------------

{6}------------------------------------------------

VII.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 IPL Home Use Hair Removal Device 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

{7}------------------------------------------------

IEC 60601-2-57 Medical electrical equipment –Part 2-57: 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 Home Use Hair Removal Device was found to have a safety and effectiveness profile that is similar to the predicate device.

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 Home Use Hair Removal Device 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.