IPL Hair Removal Device Model: TB-1755, a small over-the-counter device for the permanent reduction of hair growth based on 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. A personal Light-Based Hair Removal System. Emission activation is by finger switch. Device includes a treatment window head, an adaptor and goggles. The size of the device is about 185 x 72.4 x 69.2mm (H x W x D). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Removal Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.

AI/ML Overview

The provided text is a 510(k) Summary for an IPL Hair Removal Device (Model: TB-1755). This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a detailed study with specific acceptance criteria and performance data for the subject device in the way one might expect for a diagnostic or AI-driven device.

Therefore, the requested information, specifically regarding acceptance criteria, reported performance from a study, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is largely not present in this type of regulatory submission.

Here's an explanation based on the provided text, highlighting what is available and what is not:

Request for Acceptance Criteria and Device Performance Study

The provided document, a 510(k) Summary, describes a process for market clearance based on "substantial equivalence" to legally marketed predicate devices, not on proving absolute efficacy against predetermined acceptance criteria for a novel device through a clinical study. As such, the specific information requested in your prompt detailing acceptance criteria and performance statistics of a study is not explicitly available in this document.

The "study" mentioned mainly refers to bench testing against recognized safety and performance standards for medical electrical equipment and biological evaluation (e.g., IEC and ISO standards), and a comparison of the subject device's specifications and indications for use against predicate devices.

Here's what can be extracted and what cannot:

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

Acceptance Criteria (Implicit): The implicit acceptance criteria are that the device adheres to the relevant IEC and ISO standards listed for safety (electrical, EMC, biological evaluation) and that its performance specifications (e.g., wavelength, fluence, pulse duration) are similar to or within the ranges of the predicate devices, and do not raise new questions of safety or effectiveness.
Reported Device Performance: No explicit performance data (e.g., hair reduction percentage, adverse event rates in a clinical trial) from a specific study on the subject device is reported in this summary. The summary focuses on showing that the device meets standards and is comparable to already cleared devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. This document does not describe a clinical test set or participant sample size for evaluating hair removal efficacy. The "tests" mentioned are primarily laboratory bench tests for compliance with electrical, electromagnetic, and biocompatibility standards.

3. 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/Not provided. This type of information is pertinent to studies involving expert review for diagnostic accuracy or clinical outcomes, which is not the focus of this 510(k) summary.

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

Not applicable/Not provided. The testing mentioned is for technical compliance and safety, not for clinical adjudication of outcomes.

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

Not applicable/Not provided. This device is an IPL hair removal device, not a diagnostic imaging device involving human readers or AI assistance in interpretation.

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

Not applicable/Not provided. This is not an AI-driven device or an algorithm for standalone performance evaluation.

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

Implicit Ground Truth for Bench Tests: The "ground truth" for the bench tests is adherence to the specifications defined by the referenced IEC and ISO standards and the performance characteristics observed in the laboratory environment. For the substantial equivalence argument, the "ground truth" is that the predicate devices are legally marketed and considered safe and effective for their intended use.
No clinical outcomes data as ground truth is described for the subject device.

8. The sample size for the training set

Not applicable/Not provided. This applies to machine learning models, which is not relevant to this device.

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

Not applicable/Not provided. As above, this is not a machine learning device.

Summary of available information related to "testing" and "performance":

The "Test Summary" section (Section 7) on page 5 details that the IPL Hair Removal Device's safety and performance were evaluated by lab bench testing according to several standards:

Safety Standards (Electrical, EMC, Home Healthcare, Specific to non-laser sources):
- IEC 60601-1 (General Safety)
- IEC 60601-1-2 (Electromagnetic Compatibility - EMC)
- IEC 60601-1-11 (Home Healthcare Environment)
- IEC 60601-2-57 (Non-laser source equipment for therapeutic/cosmetic use)
Biological Evaluation Standards:
- ISO 10993-5 (In Vitro Cytotoxicity)
- ISO 10993-10 (Irritation and Skin Sensitization)
Software Guidance:
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Indicates software control is present, as seen in the comparison table)

The "Comparison to Predicate Device" section (Section 8) on pages 5-6 indicates that the subject device's design principles, intended use, indications for use, functions, material, and applicable standards are "very similar" to the predicate devices. Differences in specifications like wavelength range, spot size, max fluence, pulse duration, and output energy are noted but deemed not to affect safety and effectiveness because they are "similar to the predict devices', or under their ranges" and the "safety and effectiveness of the subject device is verified via tests" (referring to the bench tests mentioned above).

Conclusion: The document confirms that the device underwent specific technical and biological safety tests to demonstrate compliance with recognized standards. However, it does not include data from a clinical effectiveness study with human participants, specific acceptance criteria for hair removal efficacy, or the other detailed study parameters requested in your prompt. The clearance is based on substantial equivalence, relying on the established safety and effectiveness of the predicate devices and the subject device's compliance with safety standards.

Summary

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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 is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. % Jet Li Regulation Manager Guangzhou KEDA Testing Tech Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District GuangZhou, CN

February 15, 2019

Re: K183217

Trade/Device Name: IPL Hair Removal Device 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 ONF Dated: November 10, 2018 Received: November 19, 2018

Dear Jet Li:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Image /page/1/Figure/5 description: This image shows a digital signature and associated information. The signature is from Neil R Ogden -S, and the date is 2019.02.15 at 08:56:30 -05'00'. The signature is for Binita S. Ashar, M.D., M.B.A., F.A.C.S., who is the Director of the Division of Surgical Devices, Office of Device Evaluation, and Center for Devices and Radiological Health.

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K183217

Device Name

IPL Hair Removal Device (Model: TB-1755)

Indications for Use (Describe)

The IPL Hair Removal Device (Model: TB-1755) is an Over the Counter device intended for the removal of unwanted body 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 Druq 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."

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K183217 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 878.4810.

Submitter Information 1.

� Company Name: Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.
� Establishment Registration Number: Applying
� Address: 7/F, Marina Bay Centre A, South of Xinhua Road, Bao'an Centre Area, Xin'an Street Bao'an District, Shenzhen, China.
� Phone: +86 755-3366 2222
� FAX: +86 755-3366 8880
Contact Person (including title): Aaron Zhai (Engineer) �
� E-mail: bz@touchbeauty.com

2. Application Correspondent

Company Name: Guangzhou KEDA Testing Tech Co., Ltd. �
� Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhou City, China
� Contact Person: Mr. Jet Li
Title: Regulation Manager �
� Tel: +86-20-22325619
� Email: med-jl @foxmail.com

Subject Device Information 3.

� Type of 510(k) submission: Traditional
� Common Name: Light Based Over-The-Counter Hair Removal
� Trade Name: IPL Hair Removal Device
Classification Name: Laser surgical instrument for use in general and plastic surgery and in �

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dermatology

� Review Panel: General & Plastic Surgery
� Product Code: OHT
� Regulation Number: 21 CFR 878.4810
� Regulation Class: 2

4. Predicate Device Information

Sponsor	Trade Name	510(k) number	Product Code	Approval Date
CyDen Limited	iPulse SmoothSkin GoldHair Removal System	K160968	OHT	April 14, 2016
Shen ZhenCosBeauty Co., Ltd	Perfectsmooth	K161428	OHT	March 23, 2017

5. Device Description

The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Removal Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.

Intended Use 6.

The IPL Hair Removal Device (Model: TB-1755) is an Over the Counter device intended for the removal of unwanted body hair.

7. TestSummary

IPL Hair Removal Device has been evaluated the safety and performance by lab bench testing according to the following standards:

IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005+A1:2012

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IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2014
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 -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
ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff

8. Comparison to Predicate De vice

Compare with predicate devices, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate devices do not raise any new questions of safety or effectiveness.

Elements ofComparison	Subject Device	Primary Predicate Device 1	Predicate Device 2	Verdict
Manufacturer	Touchbeauty Beauty &Health (Shenzhen) Co.,Ltd.	CyDen Limited.	ShenZhen CosBeautyCo., Ltd	--
ProductName	IPL Hair RemovalDevice	iPulse SmoothSkin Gold HairRemoval System	Perfectsmooth	--
510(K) No.	Applying	K160968	K161428	--
Elements ofComparison	Subject Device	Primary Predicate Device 1	Predicate Device 2	Verdict
Indicationsfor Use	The IPL Hair RemovalDevice (Model: TB-1755) is an Over theCounter device intendedfor the removal ofunwanted body hair.	The iPulse SmoothSkin GoldHair Removal System isindicated for the removal ofunwanted hair. The iPulseSmoothSkin Gold is alsoindicated for the permanentreduction in hair regrowth,defined as the long-term,stable reduction in thenumber of hairs regrowingwhen measured at 6, 9 and12 months after thecompletion of a treatmentregime.	The IPL Hair RemovalDevice Joy Version isan over-the-counterdevice intended forremoval of unwantedhair such as but notlimited to small areassuch as underarm andfacial hair below thechin line and largeareas such as legs.	SENote 1
IFU Type	Over-The-Counter	Over-The-Counter	Over-The-Counter	SE
ClassificationProduct Code	OHT	OHT	OHT	SE
Device Type	Intense Pulsed Light	Intense Pulsed Light	Intense Pulsed Light	SE
Device Design
Power source	an external power supply	AC Mains	an external power supply	SENote 2
Light source	Xenon Arc Flashlamp	Xenon Arc Flashlamp	Xenon Arc Flashlamp	SE
Wavelength	510nm~1100nm	510nm~1100nm	475nm~1200nm	SENote 2
Spot Size	3.1 cm²	3 cm²	4.5 cm²	SENote 2
Max. Fluence(J/cm²)	3.8-5.2 J/cm²	3-6 J/cm²	4.7 J/cm²	SENote 2
Pulse duration	3 milliseconds	2-10 milliseconds	11-13 milliseconds	SENote 2
Output energy	12-16 J	9-18 J	< 22 J	SENote 2
PulsingControl	Finger switch	Finger switch	Finger switch	SE
OutputChannel	One channel	One channel	One channel	SE
Delivery	Direct Illumination to	Direct Illumination to Tissue	Direct Illumination to	SE
Elements ofComparison	Subject Device	Primary Predicate Device 1	Predicate Device 2	Verdict
Device	Tissue		Tissue
SoftwareControl	Yes	Yes	Yes	SE
Dimensions	18272.469.2mm	1323565mm		SENote 2
FDA-Recognized Standards
Electricalsafety, EMC,BiologicalEvaluation	IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57IEC 62471ISO 10993-5ISO 10993-10	IEC 60601-1IEC 60601-1-2IEC 62471ISO 10993-5ISO 10993-10ISO 10993-12	IEC 60601-1IEC 60601-1-2IEC 60601-2-57IEC 62471ISO 10993-5ISO 10993-10	SENote3

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Note 1

Although there is little difference about the indication for use, the application of the subject device is only the removal unwanted hair, such as back, legs &arms, armpits and bikini areas, except the face and other delicate areas. Besides, the subject device isn't applied to long-term, stable reduction. This difference does not affect the safety and effectiveness.

Note 2

Although the device design between the predicate devices and subject device are mainly equivalent, the specifications of subject device are not completely same. Even so the key specifications of subject device is similar to the predict devices', or under their ranges. After all, the safety and effectiveness of the subject device is verified via tests, so the differences do not affect the safety and effectiveness.

Note 3

Although the subject takes more applicable FDA-recognized standards for reference, so the differences do not affect the safety and effectiveness.

9. Conclusion

The subject device, IPL Hair Removal Device (Model: TB-1755), is substantially equivalent to the predicate devices.

10. Summary Prepared Date

14 Feb 2019

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.