The Sensilight Pro device is an over-the-counter device intended for the removal of unwanted body and/or facial hair. Sensilight Pro is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured 6,9 and 12 months after the completion of treatment regimen.

Device Description

The Sensilight Pro is an intense pulse light hair reduction device. Phototherapy (Lightbased) hair reduction is based on the theory of selective photothermolysis in which optical energy is used to disable hair re-growth. The Sensilight Pro is composed of a hand-held applicator and an external power supply/charger. The spot size (treatment area) in the Sensilight Pro is 4.5 cm² or 2 cm² (for large and precise treatment windows, respectively).

The device contains a lamp, a skin proximity and pigmentation sensor allowing application only on compatible skin tones and while in full contact with the treated area. If the Sensilight Pro is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the device will provide indications on the faulty conditions and will not trigger a pulse.

AI/ML Overview

The Sensilight Pro device, intended for over-the-counter hair removal and permanent hair regrowth reduction, did not report specific acceptance criteria in the provided text. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through various tests and comparisons.

Here's an analysis of the provided information, structured to address your points:

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) were not explicitly defined in the provided text, they cannot be presented in a table. The performance evaluation primarily centered on safety, compliance with standards, and human factors validation.

However, we can infer some performance aspects from the human factors studies:

Performance Aspect	Reported Device Performance
Label Comprehension/Self-Selection	100% of 25 participants reported correct answers regarding intended use, treatment areas, and contraindications.
Usability/User Interface	100% success rate for all tasks (25 tasks across 4 scenarios) completed by participants without moderator assistance. Average satisfaction with ease of use: 4.4 ± 0.2 (on a 1-5 scale). Average labeling and instructions comprehension: 4.1 ± 0.2. Overall satisfaction: 4.1 ± 0.2. Minimal negative feedback (two found it heavy, one found triggerless mode unnecessary).
Safety (via standards compliance)	The device has been tested and complies with numerous international and industry standards, including: - IEC 60601-1:2012/EN 60601-1:2013 (Ed. 3.1) for basic safety and essential performance. - IEC 60601-1-11:2015 (Ed. 2) for home healthcare environment. - IEC 60601-2-57:2011 (Ed. 1) for non-laser light source equipment. - FCC part 15, Subpart B, Class B. - IEC 60601-1-2:2014 (Ed. 4) for electromagnetic compatibility. - IEC 62471:2006 (Ed. 1) for photo-biological safety. - IEC 62304:2006 for medical device software life cycle processes. - ISO 10993-1:2009 for biological evaluation. - ISO/IEC 14971:2007 (BS EN ISO 14971:2012) for risk management. - CB IEC 62133:2012 and UN 38.3 for battery safety and transport.

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

Labeling Comprehension/Self-Selection Study:
- Sample Size: 25 participants (4 men, 21 women).
- Data Provenance: Not explicitly stated, but based on the overall context of a submission to the US FDA, it would typically be conducted within the US or a region compliant with US regulatory requirements. The study appears to be prospective as participants were "enrolled" and received materials for evaluation.
Usability/User Interface Study:
- Sample Size: 25 participants initially ("all tasks were completed by 100% of the participants"), but the follow-up satisfaction questionnaire was filled by 18 of the 20 users. This suggests that the study may have involved 20 users for the primary usability tasks with 18 completing the satisfaction survey, or 25 for tasks and 18 for satisfaction. Clarification is needed, but 25 is the stated size for task completion.
- Data Provenance: Not explicitly stated regarding country, but appears prospective as participants performed tasks with the device.

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

There is no mention of experts being used to establish ground truth in the context of these human factors studies for the Sensilight Pro. The "ground truth" for these studies was the ability of the general public (participants) to comprehend labeling and successfully operate the device without assistance.

4. Adjudication Method for the Test Set

Labeling Comprehension/Self-Selection Study: Answers were "further validated by the moderator." This implies a form of human review/adjudication. The text states "with correct answers: 'Yes' or 'No', explenation and further validation by the moderator."
Usability/User Interface Study: The adjudication method for tasks was based on direct observation of task completion, with the "success rate (pass criteria) was 100% per each task scenario." No specific expert adjudication process beyond the moderator's observation 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

No MRMC study was performed or reported. This device is an IPL hair removal device, not an AI-assisted diagnostic or interpretive system that would typically involve human "readers" or an MRMC study.

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

Not applicable in the AI sense. The Sensilight Pro is a medical device, not an AI algorithm. Its "standalone" performance is established through bench testing (safety, electrical, mechanical, photobiological, etc.) and compliance with various standards (listed in point 1). These tests ensure the device functions correctly and safely on its own.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For Human Factors Studies:
- Labeling Comprehension: The "ground truth" was predefined correct answers to comprehension questions, potentially established by the device manufacturer's regulatory/clinical team.
- Usability: The "ground truth" was verifiable task completion based on the device's design and instructions.
For Clinical Efficacy (Hair Reduction): The document explicitly states: "No new clinical performance data is reported in this submission."
Therefore, the ground truth for hair reduction efficacy for this submission was not directly established via new clinical studies. Instead, substantial equivalence to predicate devices (which presumably had established clinical efficacy) was argued based on similar technology and parameters. The stated definition of "permanent reduction in hair regrowth" (measured 6, 9, and 12 months after treatment) implies that outcomes data would be the typical ground truth for this claim, but this was not provided for the Sensilight Pro in this submission.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product requiring a training set in the conventional sense. The "training" for the device's design and features would be through engineering development, safety testing, and compliance with standards.

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

Not applicable, as there's no "training set" for this type of device. The design and safety features (like skin proximity and pigmentation sensors) were developed and validated through internal testing and compliance with recognized standards, which serve as the implicit "ground truth" for their proper functioning.

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 acronym along with the words "U.S. Food & Drug Administration" on the right. The FDA part of the logo is in blue, with the acronym in a square and the words in a smaller font below.

EL Global Trade Ltd. Shachar Raz RA/OA manager 8 Tzoran St, P.O. Box 8242 Netanya, 4250608 IL

March 18, 2019

Re: K183260

Trade/Device Name: Sensilight Pro / Pistol IPL 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: February 13, 2019 Received: February 19, 2019

Dear Shachar Raz:

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 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

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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.

Digitally signed by Neil R Neil R Ogden -S Date: 2019.03.18 Ogden -S 15:22:34 -04'00' Binita S. Ashar, M.D., M.B.A., F.A.C.S. For 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) K183260

Device Name Sensilight Pro

Indications for Use (Describe)

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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EL Global Trade Ltd	Tzoran 4th St, P.O.Box 8242, Netanya 4250608, IsraelTel: +972-9-7889069 Fax: +972-9-7734831
Sensilight Pro – 510K submission	RD-18062 A0

SECTION 05

SENSILIGHT PRO

AN OVER-THE-COUNTER HOME USE DEVICE INTENDED FOR HAIR REDUCTION BASED ON INTENSE PULSED LIGHT (IPL)

510(K) SUMMARY

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EL Global Trade Ltd

Tzoran 4th St, P.O.Box 8242, Netanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831

Sensilight Pro – 510K submission

RD-18062 A0

510(K) SUMMARY FOR EL GLOBAL TRADE LTD'S SENSILIGHT PRO

DATE PREPARED: MARCH 18, 2019

1. 510(K) OWNER NAME

EL Global Trade Ltd. Tzoran 8th st, P.O.Box 8242, Netanya 4250608, Israel. Phone: +972-9-7889067, Fax: +972-9-7734831.

Contact person name: Dr. Shachar Raz, RA/QA manager Phone: (213) 335-3521, E mail: ra_qa@homewellt.com

2. DEVICE NAME

Common/Usual Name: Light based hair removal devices Proprietary/Trade name: Sensilight Pro or Pistol IPL Device Classification: Sensilight Pro by EL Global Trade Ltd has been classified as Class II device under the following classification names:

Classification Name	ProductCode	RegulationNumber	Panel
Light Based Over-The-Counter Hair RemovalandPowered Light BasedNon-Laser SurgicalInstrument With ThermalEffect	OHTandONF	878.4810	General and PlasticSurgery

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3. PREDICATE DEVICES

Sensilight Pro by EL Global Trade Ltd. is substantially equivalent to the following Predicate Devices:

3.1 Home Well Trading LTD's Beurer IPL 8500 Device, cleared under 510(k) number K181734 on September 19, 2018

3.2 EL Global Trade Ltd.'s sensiLight Mini,

cleared under 510(k) number K161089 on July 08, 2016

4. DEVICE DESCRIPTION

Body contact materials were evaluated for biocompatibility with accordance to FDA's Memorandum - #G95 1, May 1, 1995 and ISO 10993-1:2009.

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RD-18062 A0

5. INTENDED USE

The Sensilight Pro is an over the counter device intended for removal of unwanted body and/or facial hair in adults. The Sensilight Pro is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

Sensilight Pro relies on the same technology as both predicate devices: Intense Pulsed Light (IPL). The safety and efficacy of IPL treatment for hair reduction are governed by the following parameters:

. Wavelength of the emitted light (spectrum): Defines the interaction with specific chromophores (the part of the molecule responsible for its color) such as melanin, hemoglobin and water. Sensilight Pro and the predicate devices utilize the same spectrum as the Beurer IPL 8500 device (475-1200nm/550-1200nm) and the sensiLight mini predicate device (475-1200nm).
. Fluence/flux - defines the energy per area (e.g. joules per cm2) for the treatment. Sensilight Pro and the predicate devices deliver exactly the same maximum energy (5 joules/cm2).
. Pulse duration - Provides for an efficient heating of the target molecule but not its surroundings. Sensilight Pro and the predicate devices has exactly the same pulse duration.

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7. PERFORMANCE DATA (BENCH)

Sensilight Pro by EL Global Trade Ltd. has been successfully tested through bench and safety tests to support the determination of substantial equivalence with predicate devices.

Sensilight Pro has been tested and complies with the following voluntary recognized standards:

1. IEC 60601-1:2012/EN 60601-1:2013 (Ed. 3.1). Medical electric equipment-Part 1 General requirements for Basic safety and essential performance.
1. IEC 60601-1-11:2015 (Ed. 2). Medical electric equipment-Part 1: Collateral requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
1. IEC 60601-2-57:2011 (Ed. 1). Medical electrical equipment-Part 2: Particular requirements for basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetics/aesthetic use.
1. FCC part 15, Subpart B, Class B.
1. IEC 60601-1-2:2014 (Ed. 4) Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility – Requirements and tests.
1. IEC 62471:2006 (Ed. 1). Photo-biological safety of lamps and lamp systems.
1. Software Validation was conducted according to IEC 62304:2006 Medical device software - Software life cycle processes, and; FDA Guidance for the Content of Pre-Market Submissions for Software Contained in Medical Devices, dated May 11, 2005.
1. ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process and with FDA's Memorandum – #G95 1, May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (Blue Book Memo G95-1).

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1. ISO/IEC 14971:2007 (BS EN ISO 14971:2012) Medical devices Application of risk management to medical devices.
1. CB IEC 62133:2012. Secondary cells and batteries containing alkaline or other nonacid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications.
11.UN 38.3 Recommendations on the Transport of Dangerous Goods, Model Regulations: Lithium Battery Transporation

*For the complete list of tests and applicable standards see Sensilight Pro Traceability

Analysis, RD-18052 (Appendix C- subsection 038).

Tests results are supporting all labeling claims in order to establish substantial equivalency.

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RD-18062 A0

Human Factors Validation Testing

A human Factors Validation Testing was done to evaluate the HFE/ UE concerns, including label comprehension/self-selection and usability/user interface studies (one arm, simulated use and summative evaluation). In both studies, participants had received the labeling materials of the device, and given enough time to read it according to their own wish.

Labeling Comprehension/ Self Selection Study was aimed at demonstrating potential user comprehension of the device labeling (mainly the outer package) in order to decide if device use is appropriate for her. It had included three main questions regarding the intended use of the device, treatment areas and possibility to use the device according to the contraindication, with correct answers: "Yes" or "No", explenation and further validation by the moderator. A total of 25 participants, 4 men and 21 women, from age 23 to 75 years old (37 ± 14 years old) were enrolled to this study. Participants had different educational levels, as obtained by REALM testing with 28% below 90 grade level. All participants had met the inclusion/ exclusion criteria and signed ICF. 100% of the participants had reported correct answers, as further validated by the moderator («=1).

Usability/ User Interface Study was aimed at demonstrating the OTC user can correctly use the device, based on the labeling material for the intended aesthetic puspose. The study was focused on four use scenarios including 25 relevant tasks: "Getting to know the device and device set-up" (7 tasks). "self-preparation" (9 tasks). "device usage" (7 tasks) and "after usage" (2 tasks). None of the participants had required assistance from the moderator while performing the tasks. Altogether, all tasks were completed by 100% of the participants, and the success rate (pass criteria) was 100% per each task scenario.

In addition, in the follow up satisfaction questionnaire, filled by 18 of the 20 users, all participants (18) commented that the device usage is easy and clear with an average result of 4.4±0.2, using a 1-5 discrete scale (when 1 represents worst and 5 represents best). Labeling and instructions comprehension result was 4.1±0.2 and overall satisfaction was

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EL Global Trade Ltd	Tzoran 4th St, P.O.Box 8242, Netanya 4250608, IsraelTel: +972-9-7889069 Fax: +972-9-7734831
Sensilight Pro – 510K submission		RD-18062 A0

at 4.1±0.2. Two participants found the device to be somewhat heavy and a single user found the trigger less mode to be unnecessary.

These two demonstrate that the intended OTC users can understand the package labeling, correctly choose the device and use it for the indicated aesthetic use, based solely on reading the lableling materials.

CLINICAL PERFORMANCE DATA 8.

No new clinical performance data is reported in this submission.

SUBSTANTIAL EQUIVALENCE 9.

Sensilight Pro by EL Global Trade Ltd. is substantially equivalent to the selected predicate devices in terms of indication for use, technology, performance, areas of usage, patient population and nature of body contact.

The Substantial equivalence decision was based on the following comparison with the predicate devices:

The design and components in Sensilight Pro, including the hand-held applicator (with lamp, microcontroller, fan, skin color and proximity sensors, indicator LEDs and operational button/s), are similar to the design and components found in the predicate devices (K161089 and K181734). The performance specifications (including light energy power, wavelength and pulse duration) are identical. The safety features found in the devices are the same, including the skin color sensor, skin proximity sensor, etc. These safety features in Sensilight Pro are substantially equivalent to the safety features found in the predicate devices. Any minor differences in the characteristics do not raise new safety or effectiveness concerns. Furthermore, the new Sensilight Pro underwent performance testing, including software validation testing and electrical and mechanical safety testing according to IEC 60601-1 and electromagnetic compatibility testing according to IEC 60601-1-2.

..............................................................................................................................................................................

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EL Global Trade Ltd	Tzoran 4th St, P.O.Box 8242, Netanya 4250608, IsraelTel: +972-9-7889069 Fax: +972-9-7734831
Sensilight Pro – 510K submission	RD-18062 A0

10. CONCLUSIONS

The evaluation of our device performances and comparison to the predicate devices demonstrate that it is substantially equivalent to the 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.