Epilaser is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Epilaser is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. Permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.

Device Description

The Epilaser is an over-the-counter, hand-held, hair removal device intended for hair removal on the face below the nose, underarms, and bikini line. It kills the root of the hair follicle using focused laser energy. The system has an integrated microscope and external viewing screen which allows the user to visualize and target individual hairs. The system is composed of a hand held laser containing multiple safety features and a dedicated viewing screen.

AI/ML Overview

The provided text is a Food and Drug Administration (FDA) 510(k) summary for the "Epilaser" device. It outlines the device's intended use, technological characteristics, and performance data to establish substantial equivalence to a predicate device.

However, the document does not contain specific acceptance criteria for device performance (e.g., efficacy in hair reduction rates) nor the results of a study that directly proves the device meets such criteria. Instead, it focuses on demonstrating safety, usability, and technical equivalence to a predicate device.

Therefore, many of the requested items (e.g., a table of acceptance criteria with reported performance, sample sizes for test/training sets with ground truth details, MRMC study results, standalone performance) cannot be extracted from this document as the information is not present.

Here's an attempt to answer the questions based only on the provided text, indicating where information is missing:

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

The document does not provide a table with specific performance acceptance criteria (e.g., a minimum percentage of hair reduction) or corresponding measured performance values for the Epilaser. The "Performance Data" section lists various tests conducted (biocompatibility, software, safety, usability, laser energy characterization) rather than efficacy-based acceptance criteria or results.

Efficacy is implicitly addressed by stating it has "identical laser output parameters" to the predicate, implying similar efficacy without explicitly stating performance metrics.

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

The document mentions "Usability testing that showed that all subjects were successful at determining who should use the device and on what anatomic locations the device should be used." It also states, "In addition, the intended users were successful at performing all critical tasks, with only one user failing in one of the tasks due to abandoning the instructions in the middle of the procedure."

Sample Size for Test Set: The exact number of subjects for usability testing is not specified, only "all subjects" and "one user."
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective).

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)

This information is not provided in the document. The usability testing seems to rely on user performance rather than expert-established ground truth related to clinical efficacy.

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

This information is not provided 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

There is no mention of a multi-reader multi-case (MRMC) study or any AI component in the Epilaser device. The device described is a direct-use laser hair removal system.

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

Not applicable. The Epilaser is a physical device used by a human, not an algorithm. The "standalone" concept for algorithms does not apply here.

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

For the usability testing, the "ground truth" was likely the successful completion of tasks by the users. For the substantial equivalence claim regarding efficacy, it relies on the predicate device's established efficacy, indirectly using its original "outcomes data" or clinical evidence, but no direct ground truth generation for the Epilaser's efficacy is described in this document.

8. The sample size for the training set

Not applicable. The document describes a physical medical device, not a machine learning algorithm requiring a "training set" in the computational sense.

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

Not applicable, as there is no mention of a training set for an algorithm.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

September 1, 2017

Epilady 2000 LLC % John Smith, M.D., J.D. Hogan Lovells US LLP 555 Thirteenth Street. NW Washington, District of Columbia 20004-1109

Re: K170970

Trade/Device Name: Epilaser 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: GEX Dated: June 23, 2017 Received: June 23, 2017

Dear Dr. Smith:

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 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 (DICE) 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" (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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) 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.

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) K170970

Device Name Epilaser

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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K170970 510(k) SUMMARY

Epilady 2000's Epilaser

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Epilady 2000 LLC 3 Hacharash St., Industrial Zone Hazor Haglilit, Israel 1035102

Joseph Miller, Managing Director (p) +972 4 686 0400 (f) +972 4 686 0500 yossie@Epilady.com

Date Prepared: August 29, 2017

Name of Device

Epilaser

Common or Usual Name

Powered laser surgical instrument, GEX

Classification Name

21 CFR 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology, class II

Predicate Devices

TRIA Laser Hair Removal System, TRIA Beauty, Inc. (K090820, K120737)

Device Description

Intended Use/Indications for Use

Epilaser is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Epilaser is also intended for permanent reduction in hair

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regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. Permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.

Summary of Technological Characteristics

The Epilaser is composed of four lasers, a focusing objective, a microscope subassembly, a mechanical key lock, an operation button, an electro-optical sensor, a touch sensor, a battery, an LED, and housing.

The Epilaser is substantially equivalent to the TRIA Laser Hair Removal System, TRIA Beauty Inc. (K090820, K120737). The Epilaser has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. Importantly, the two systems have identical laser output parameters. The systems primarily differ in that the Epilaser uses a microscope objective to allow the user to target individual hairs, whereas the predicate system treats a larger area. The minor technological differences between the Epilaser and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Epilaser is substantially equivalent to the TRIA.

Performance Data

The following tests were conducted to establish substantial equivalence:

. Biocompatibility testing per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization and irritation).
. Software documentation and validation per "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
. Electrical, EMC, and laser safety testing per AAMI/EN 60601-1, AAMI/EN EC 60601-1-2, IEC 62471, IEC 60825-1, IEC 60335-2-23, and EN 55014-1.
Usability testing that showed that all subjects were successful at determining who . should use the device and on what anatomic locations the device should be used. In addition, the intended users were successful at performing all critical tasks, with only one user failing in one of the tasks due to abandoning the instructions in the middle of the procedure. This subject was able to perform the task after completely reading the instructions.
Laser energy deposition at various depths characterization

Conclusions

The Epilaser has the same intended use and identical laser output parameters to the predicate TRIA laser. Safety testing has shown that the Epilaser conforms to applicable electrical, EMC, and laser safety standards. Usability testing demonstrated that users can self-select and use the device. Therefore, the Epilaser is substantially equivalent to the predicate device.

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.