The sensiLight Mini is an over the counter devices intended for the removal of unwanted hair. The sensiLight Mini is also intended for permanent reduction in hair regrowth, 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.

Device Description

The sensiLight Mini device is pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The sensiLight Mini device is composed of a hand held applicator and an external power supply. The spot size (treatment area) in the sensiLight Mini device is 3 cm2. The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the sensiLight Mini is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the sensiLight Mini will not trigger a pulse.

AI/ML Overview

The provided document describes the sensiLight Mini, a pulsed light hair removal device. However, it does not include specific acceptance criteria or a study that directly proves the device meets those criteria in the typical sense of a clinical trial with predefined endpoints and statistical analysis.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various tests and comparisons of technological characteristics. The "Performance Data" section primarily lists compliance with recognized standards and non-clinical testing.

Here's an attempt to extract and synthesize the requested information based on the provided text, acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria with numerical targets are not stated, I will infer them from the safety and usability tests described and the claim of "substantial equivalence."

Acceptance Criteria (Inferred)	Reported Device Performance
Safety:
- Biocompatibility	Body contact materials evaluated for biocompatibility per FDA Memorandum #G95 1 and ISO 10993-1:2009.
- Electrical & Mechanical Safety	Complies with IEC 60601-1:2005/EN 60601-1:2006, IEC 60601-1-11:2010, IEC 60601-2-57:2011.
- Electromagnetic Compatibility (EMC)	Complies with FCC part 15. Subpart B, Class B, and IEC 60601-1-2:2007.
- Software Safety	Software Validation conducted according to IEC 62304:2006 and FDA Guidance for Software Contained in Medical Devices (May 11, 2005).
- Risk Management	Complies with ISO/IEC 14971:2007 (BS EN ISO 14971:2012).
- Safety Features (skin proximity/pigmentation) functionality	Device contains a skin proximity sensor and a skin pigmentation sensor. Will not trigger a pulse if not properly applied or if skin tone is too dark/tanned. These features are "the same" as predicate devices.
Usability & Effectiveness:
- Intuitive Use / Self-Selection	Usability Study demonstrated that potential end users could self-select appropriately, and 100% of enrolled subjects successfully completed all tasks using the device and instructions in a simulated home environment.
- Effectiveness claims supported (hair removal, permanent	"Tests results are supporting all labeling claims in order to establish substantial equivalency." (The specific hair reduction percentages or clinical equivalency data are not provided in this document, but rather a claim that supporting test results exist). Predicate devices provide the basis for these claims.
hair reduction)
Technological Equivalence to Predicate Devices:
- Wavelength of light emitted	Same as predicate devices (475 - 1200nm).
- Fluence/flux (energy per area)	Same as predicate devices (5 joules/cm² maximum energy).
- Pulse duration	Same as predicate devices.
- Design and components	Similar to predicate devices (K131870 and K103184).

Regarding the studies: The document describes one non-clinical "Usability Study" as part of the performance data. It does not describe a clinical study in the traditional sense to prove efficiency for hair removal, but rather relies on substantial equivalence to previously cleared predicate devices for those claims.

2. Sample Size and Data Provenance (for the described Usability Study)

Sample size: 20 potential device end-users were enrolled in the Usability Study. (3 participants were excluded during self-selection screening).
Data provenance: Not explicitly stated, but it was a simulated home-use environment, indicating a prospective study specifically for this device. The country of origin for the data is not mentioned, but given the company's location (Israel), it's plausible the study was conducted there.

3. Number of Experts and Qualifications (for the Usability Study)

No experts were used to establish ground truth for the usability study. The study objective was to test the device's self-selection and usability by potential end-users (lay users), not experts.

4. Adjudication Method (for the Usability Study)

There was no mention of an adjudication method. The study involved participants completing tasks, and "All of the 20 enrolled subjects (100%) completed all tasks successfully." This suggests direct observation and binary outcome (task completed/not completed) rather than a need for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The device is a user-operated hair removal device, not an imaging or diagnostic AI tool that would typically involve multiple human readers interpreting cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

The document implies standalone performance of the device's safety mechanisms (skin proximity and pigmentation sensors) as they automatically prevent pulsation if conditions are not met. However, the overall device function requires human operation. The document doesn't detail an "algorithm-only" performance in the context of an AI device, as this is a physical light-based device. If we interpret "standalone" as the device operating as intended without human intervention in its safety features, then yes, those features function standalone.

7. Type of Ground Truth Used (for the Usability Study)

For the Usability Study, the "ground truth" was the successful completion of predetermined tasks by the lay users. It was based on direct observation of user interaction with the device and instructions, not expert consensus, pathology, or outcomes data in a medical sense.

8. Sample Size for the Training Set

The document does not describe the development of an AI algorithm with a training set for this device in the common sense. It's a light-based physical device with embedded software and sensors. Therefore, there's no "training set" sample size to report for an AI model.

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

As there's no mention of a traditional AI training set, this question is not applicable to the information provided. The "ground truth" for the device's safety features (e.g., what constitutes appropriate skin tone or proper contact) would have been established during engineering design and testing, likely through physical measurements and pre-defined parameters rather than a data-driven training set for an AI model.

Summary

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Tzoran 4th St, P.O.Box 8242, Netanya 42504, Israel EL Global Trade Ltd Tel: +972-9-7889069 Fax: +972-9-7734831 sensiLight Mini – 510K Hold Letter Respond RD-17025 A0

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

DATE PREPARED: JUNE 19TH, 2014

1. 510(K) OWNER NAME
  EL Global Trade Ltd. Tzoran 4th st, P.O.Box 8242, Netanya 42504, Israel. Phone: +972-9-7889069, Fax: +972-9-7734831.

Contact person name: Dr. Shlomit Segman, QA and RA manager Phone: +972-9-7889069, Fax: +972-9-7734831, E mail: Shlomit@elglobalt.com

2. DEVICE NAME

Common/Usual Name: Light based hair removal deices Proprietary/Trade name: sensiLight Mini

Classification: EL Global Trade Ltd.'s sensiLight Mini device has been classified as Class II device under the following classification names:

Classification Name	ProductCode	RegulationNumber	Panel
Light Based Over-The-Counter Hair Removal	OHT	878.4810	General and PlasticSurgery

3. PREDICATE DEVICES

EL Global Trade Ltd.'s sensiLight Mini device is substantially equivalent to the following Predicate Device:

3.1 Home Skinovations Ltd.'s Glide device, cleared under 510(k) number K131870 at August 14th, 2013.
3.2 Home Skinovations Ltd.'s Silk'n Flash N Go,

cleared under 510(k) number K103184 at November 10th, 2010.

3 1 2014

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EL Global Trade Ltd		Tzoran 4th St, P.O.Box 8242, Netanya 42504, IsraelTel: +972-9-7889069 Fax: +972-9-7734831
sensiLight Mini - 510K Hold Letter Respond		RD-17025 A0

DEVICE DESCRIPTION

The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the sensiLight Mini is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the sensiLight Mini will not trigger a pulse.

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

4. INTENDED USE

ਨ. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

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

. Wavelength of the light emitted: Defines the interaction with specific chromophores (the part of the molecule responsible for its color) such as melanin, hemoglobin and water. The sensiLight Mini device and the predicate devices utilize exactly the same wavelength (475 - 1200nm).
. Fluence/flux - defines the energy per area (e.g. joules per cm³) for the treatment. The sensiLight Mini device 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. The sensiLight Mini device and the predicate devices utilize exactly the same pulse.

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EL Global Trade Ltd	Tzoran 4th St, P.O.Box 8242, Netanya 42504, IsraelTel: +972-9-7889069 Fax: +972-9-7734831
sensiLight Mini – 510K Hold Letter Respond	RD-17025 A0

6. PERFORMANCE DATA

EL Global Trade Ltd's sensiLight has been successfully tested through bench, usability and safety tests to support the determination of substantial equivalence with predicate devices.

The sensiLight Mini device has been tested and complies with the following voluntary recognized standards:

1. IEC 60601-1:2005/EN 60601-1:2006. Medical electric equipment-Part 1 General requirements for Basic safety and essential performance, 3th Ed.
1. IEC 60601-1-11:2010. 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. 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 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility - Requirements and tests.
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).
1. IEC 60601-1-6:2010, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance and IEC 62366:2007 - Medical devices -Application of usability engineering to medical devices - Collateral stundard: Usability and FDA Guidance for Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management (July18,2000) and ISO/IEC 14971:2007 (BS EN ISO 14971:2012) Medical devices - Application of risk management to medical devices.

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

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EL Global Trade Ltd	Tzoran 4th St, P.O.Box 8242, Netanya 42504, IsraelTel: +972-9-7889069 Fax: +972-9-7734831
sensiLight Mini – 510K Hold Letter Respond	RD-17025 A0

7. NON-CLINICAL (BENCH) PERFORMANCE DATA

The objective of the Usability Study was to test the sensiLight Mini device self-selection and usability, i.e., the safe and effective device use, by potential end users, under actual use conditions.

Twenty (20) potential device end users with different Fitzpatrick skin tone and with different educational level were enrolled in the Usability Study. To strengthen the assessment that the sensiLight Mini device is intuitive and no specific training is required besides reading the Instructions for Use, self-selection was conducted in order to measure the ability of lay users to determine whether they can use the devices (based on the box labeling and instruction for use). Three participants were not enrolled to this study after self-selection screening.

The sensiLight Mini device, along with box labelling and instruction for use was provided to the participants in a simulated home use environment. The participants labeling was in the content intended for distribution. All subjects were provided with a list of tasks to complete, including applying and operating the device.

All of the 20 enrolled subjects (100%) completed all tasks successfully. The sensiLight Mini device, along with box labelling and instruction for use. can be used safely and effectively by potential end users, under actual use conditions.

8. SUBSTANTIAL EQUIVALENCE

EL Global Trade Ltd.'s sensiLight Mini is substantial equivalent to the predicate device selected in terms of indication for use, technology, performances, place of use, patient population and nature of body contact.

The Substantial equivalent decision was received based on the following comparison with the predicate device:

The design and components in the sensiLight Mini, including the hand held applicator (with lamp, microcontroller, fan, skin color sensor, skin proximity sensor, indicator LEDs and operational button/s) are similar to the design and components found in the predicate devices (K131870 and K103184). 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 the sensiLight Mini device are substantially equivalent to the safety features found in the predicate devices. Any minor differences in the technological characteristics do not raise new safety or effectiveness concerns. Furthermore, the new sensiLight Mini device underwent performance testing, including software validation testing and electrical and mechanical safety testing according to IEC 60601-1 and

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

・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ EL Global Trade Ltd. 510(k) sensiLight Mini

CONFIDENTIAL

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EL Global Trade LtdTzoran 4th St, P.O.Box 8242, Netanya 42504, IsraelTel: +972-9-7889069 Fax: +972-9-7734831
sensiLight Mini – 510K Hold Letter Respond	RD-17025 A0

electromagnetic compatibility testing according to IEC 60601-1-2. Usability testing was also successfully conducted.

9. CONCLUSIONS

The evaluation of our device performances demonstrates that it is as safe and as effective as the predicate devices.

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

y == = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 31, 2014

El Global Trade Ltd. Dr. Shlomit Segman Quality Assurance and Regulatory Affairs Manager Tzoran 4th Street, P.O. Box 8242 Netanya 42504. Israel

Re: K140527

Trade/Device Name: sensiLight Mini 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: June 25, 2014 Received: July 3, 2014

Dear Dr. Segman:

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 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 cither 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

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Page 2 - Dr. Shlomit Segman

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

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) K140527

Device Name sensiLight Mini

Indications for Use (Describe)

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

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

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Neil R Ogden -S 2014.07.31 15:45:01 -04'00'

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

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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.