Light based hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, excluding patients with Fitzpatrick Skin Phototypes VI.

Device Description

The Light based 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 IPL technology. The device consists of IPL main body and adapter two parts, and a detachable lamp cap located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is power from adapter via an external power.

AI/ML Overview

This document, K180383, is a 510(k) summary for the "Light based hair removal device" by Shenzhen GSD Tech Co., Ltd. It outlines the device's characteristics and its comparison to predicate devices to establish substantial equivalence for FDA approval.

Here's an analysis of the provided text in relation to acceptance criteria and study information:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

The document primarily focuses on establishing substantial equivalence to predicate devices rather than defining specific performance-based acceptance criteria for efficacy or hair reduction. The core of the submission is to demonstrate that the new device is as safe and effective as previously cleared devices.

The "acceptance criteria" in this context are interpreted as compliance with relevant regulatory standards and demonstrating similar technological and performance characteristics to the predicate device, implying similar safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) and not a study with specific efficacy endpoints, there isn't a direct "acceptance criteria" table in terms of clinical performance metrics (e.g., % hair reduction). Instead, the performance shown is in relation to safety and regulatory compliance.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Meet ISO 10993 standards for body-contacting parts	Passed ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation & Sensitization)
Electrical Safety: Comply with relevant IEC 60601 standards	Passed IEC 60601-1-2, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57
Eye Safety: Comply with relevant IEC standard	Passed IEC 62471 (Photobiological safety)
Software Validation: Meet software requirements for moderate level of concern	System validation testing demonstrated all software requirement specifications met and hazards mitigated
Technological Characteristics: Similar to predicate devices	Detailed comparison in Section VI showing similar intended use, energy medium, pulsing control, and mechanism of action. Differences in pulse duration, energy density, and spot size deemed not to raise safety/efficacy concerns.

2. Sample Size Used for the Test Set and Data Provenance

No human clinical study data is presented for efficacy. The studies described are engineering/laboratory tests (biocompatibility, electrical safety, eye safety, software validation).
Therefore, there is no "test set" in the context of human subjects, nor data provenance (country of origin, retrospective/prospective).

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

Not applicable. As no human clinical efficacy study is described, there is no "ground truth" established by experts in that context. The "ground truth" for the engineering tests would be the established international standards themselves, and the expertise lies with the testing laboratories performing the assessments.

4. Adjudication Method for the Test Set

Not applicable. There is no human clinical test set requiring adjudication in the document.

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. This device is a light-based hair removal device, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI-related effectiveness assessment was done or mentioned.

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

Not applicable. This is not an algorithmic device in the sense of AI. The software validation is for the device's operational software, not for an AI algorithm.

7. The Type of Ground Truth Used

For the engineering tests, the "ground truth" is the established and recognized international standards (e.g., ISO 10993 series, IEC 60601 series, IEC 62471). Compliance with these standards indicates safety and performance.

8. The Sample Size for the Training Set

Not applicable. There is no machine learning or AI component mentioned that would require a "training set."

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

Not applicable. As there is no training set for an AI algorithm, this question is not relevant.

In summary:

This 510(k) submission demonstrates the substantial equivalence of the "Light based hair removal device" by showing that it meets recognized safety and performance standards through engineering and biocompatibility testing, and that its technological characteristics are similar to those of predicate devices. It does not include clinical efficacy studies with human subjects or AI performance evaluations.

Summary

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May 11, 2018

Shenzhen GSD Tech 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, S Shenzhen, 518000 Cn

Re: K180383

Trade/Device Name: Light based 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 Dated: January 31, 2018 Received: February 12, 2018

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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. Jennifer R. Stevenson -53

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180383

Device Name Light based hair removal device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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.

Date: 2018-01-31

I. Submitter

SHENZHEN GSD TECH CO., LTD BUILDING A JUNSD HI-TECH PARK, WEST OF BAO'AN RD., WATCH & CLOCK BASE, GUANGMING DISTRICT, SHENZHEN, GUANGDONG, CHINA Tel.: +86 755 2916 9431 ext.8040 Tax: +86 755 2910 9786

Ziyi Gui Regulatory Engineer Tel: +86 130 7784 1845 Email: gzy@gsd.com.cn

II. Device

Name of Device: Light based hair removal device 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

The predicate devices are listed as below:

Manufacturer	Predicate Device	510(k) Number	Approval Date
Shen Zhen CosBeautyCo., Ltd	Perfectsmooth	K161428	March 23, 2017
CyDen Limited	iPulse SmoothSkin Gold HairRemoval System	K160968	April 04, 2016

IV. Device Description

The Light based 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 IPL

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technology. The device consists of IPL main body and adapter two parts, and a detachable lamp cap located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is power from adapter via an external power.

V. Indications for Use

VI. Comparison of Technological Characteristics With the Predicate Device

The Light based hair removal device has the same intended use, mode of action and similar operational characteristics as the predicate device. 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 Light based hair removal device may be found substantially equivalent to its predicate device.

Light based hair removal device is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.

K161428, "PerfectSmooth", manufactured by "Shen Zhen CosBeauty Co., Ltd" in Guangdong, China

ComparisonElements	Subject Device	Predicate Device 1	Predicate Device 2
K Number	Pending	K161428	K160968
Common name	Light Based Over-The-Counter Hair Removal	Light Based Over-The-Counter Hair Removal	Light Based Over-The-Counter Hair Removal
Trade name	Light based hairremoval device	PerfectSmooth	iPulse SmoothSkinGold Hair RemovalSystem
Energy medium	Xenon Arc Flashlamp	Xenon Arc Flashlamp	Xenon Arc Flashlamp
Pulse duration	2-3 milliseconds	11-13 milliseconds	2-10 milliseconds
Energy density	4.2 J/cm2Max.	4.7J/cm2Max.	3~6 J/cm2
Spot size	1.05cm×2.95cm(3.1 cm3)	4.5 cm2	3 (3cm by 1cm)
Delivery device	Direct illumination to	Direct illumination	Direct illumination

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

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ComparisonElements	Subject Device	Predicate Device 1	Predicate Device 2
	tissue	tissue	tissue
Pulsing control	Finger switch	Finger switch	Finger switch
Indicationforuse/Intended use	Light based hairremoval device is anover-the-counter deviceintended for removal ofunwanted hair such asbut not limited to smallareas such as underarmand facial hair belowthe chin line and largeareas such as legs,excluding patients withFitzpatrick SkinPhototypes VI.	The PerfectSmooth isanover-the-counterdevice intended forremoval of unwantedhair such as but notlimited to small areassuch as underarm andfacial hair below thechin line and large areassuch as legs.	The iPulse SmoothSkinGold Hair RemovalSystem is indicated forthe removal ofunwanted hair. TheiPulse Smoothskin Goldis also indicated for thepermanent reduction inhair regrowth, definedas the long-term, stablereduction in the numberof hairs regrowingwhen measured at 6, 9and 12 months after thecompletion of atreatment regime.
Location for use	OTC	OTC	OTC

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 Light based 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

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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 -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, Light based 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 Light based 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.