Epilaser Pro 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 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 Pro is an over-the-counter, hand-held, hair removal device. It kills the root of the hair follicle using laser energy at 808 or 980nm. The system includes an algorithm that automatically targets individual hairs over the treatment area and the laser activates when it is pressed against the skin. A skin tone sensor ensures the correct skin tone prior to laser activation.

AI/ML Overview

The Epilaser Pro is an over-the-counter device intended for hair removal and permanent reduction in hair regrowth. This device utilizes an algorithm to automatically target individual hairs over the treatment area. The following outlines the acceptance criteria and study details.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
True Hits	Above 90% and a greater number of True Hits than the predicate device
False Hits	A smaller number of False Hits than the predicate device
Not Safe Hits	No Not Safe Hits (indicating safe operation on the skin)
Skin Tone Identification	Correctly identified in all subjects
Safety (Adverse Effects)	At most, mild erythema and/or mild blistering, resolving within 48 hours

2. Sample size used for the test set and the data provenance

Test Set Sample Size: 69 subjects for the efficacy study.
Data Provenance: Not explicitly stated, but the submission is from "Epilady 2000 LLC" located in "Hazor Haglilit, Israel." Assuming the studies were conducted locally or within the submitting company's capabilities, it is reasonable to infer the data provenance is likely related to Israel. The study type is prospective, as it involved direct treatment and assessment of subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: One dermatologist.
Qualifications of Experts: A dermatologist was used to identify the location of hairs and pigments, and to assess skin tone. Specific years of experience are not provided, but being a dermatologist implies a high level of qualification in skin and hair assessment.

4. Adjudication method for the test set

Adjudication Method: Not explicitly stated that an adjudication method was used between multiple experts. The ground truth was established by a single dermatologist. The device performance was compared against this single expert's "Ground Truth."

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly conducted in the traditional sense of evaluating human readers' diagnostic performance with and without AI assistance. The study compared the performance of the device (Epilaser Pro with its automatic hair targeting algorithm) to the predicate device and to a dermatologist's "Ground Truth." It did not assess human reader improvement.

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

Yes, a standalone study was done. The efficacy study evaluated the "Epilaser Pro" (which includes the automatic hair targeting algorithm) and compared its performance (True Hits, False Hits, Not Safe Hits) against a dermatologist's "Ground Truth" and the predicate device. This assessment of the device's ability to detect and target hairs independently aligns with a standalone performance evaluation of the algorithm embedded within the device.

7. The type of ground truth used

Type of Ground Truth: Expert consensus (from a single dermatologist) and objective assessment. The dermatologist used a dermatoscope to objectively determine the location and number of hairs, pigmented spots, tattoos, and skin tone. This forms the "Ground Truth" for comparison.

8. The sample size for the training set

The document does not provide information regarding the sample size for the training set of the algorithm.

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

The document does not provide information regarding how the ground truth for the training set was established. The focus of the provided text is on the validation/test set.

Summary

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January 27, 2024

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

Re: K233224

Trade/Device Name: Epilaser Pro 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: December 29, 2023 Received: December 29, 2023

Dear John 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 (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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).

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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 (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Tanisha L. Tanisha L. Hithe -S 2024.01.27 Hithe -S 21:26:01 -05'00'

Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

K233224

Device Name

Epilaser Pro

Indications for Use (Describe)

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

□ Prescription Use (Part 21 CFR 801 Subpart D)

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

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K233224

510(k) SUMMARY

Epilady 2000's Epilaser Pro

Submitter

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

Moshe Rosenthal, CEO (p) +972 4 686 0400 (f) +972 4 686 0500 moshe@agrolan.co.il

Date Prepared: January 17, 2024

Device Trade Name: Epilaser Pro

Common or Usual Name: Powered laser surqical instrument

Classification Name: 21 CFR 878.4810, Class II, GEX, Laser surgical instrument for use in general and plastic surgery and in dermatology

Predicate Devices

K170970 Epilaser K213105 Epilaser Absolute

Device Description

Indications for Use

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Summary of Technological Characteristics

Both the Epilaser Pro and its predicates use light energy for permanent hair reduction. Like the Epilaser Absolute (K213105), the subject Epilaser Pro comes into two varieties, Brunette and Dark, which differ in regard to the wavelength of light they emit and the skin tones they can treat (I-IV or V-VI, respectively). The primary difference between the previously cleared Epilaser systems and the subject Epilaser Pro is the addition of an automatic hair targeting algorithm and a modification to the user interface. The company has performed validation testing to demonstrate equivalent targeting performance as compared to manual use and equivalent usability.

The Epilaser Pro has a spot size, peak power, fluence, and pulse duration that matches what has been cleared for the predicates. The company has performed laser safety testing per IEC 60601-2-22 and IEC 60825-1 to show continued safety of the modified laser systems. The user interface differ between the predicates and the Pro.

Performance Data

The following tests were conducted to establish substantial equivalence:

. Biocompatibility testing per ISO 10993-1 to assess cytotoxicity, 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 IEC 60601-1-2, IEC 62471, IEC 60825-1, and IEC 60335-2-23.
. Targeting algorithm validation to demonstrate that the algorithm detects target hairs and avoids pigmented/tattooed regions at least equivalently to the predicate (see clinical efficacy test below)
. Self-selection and usability human factors testing

Clinical Testing

Two clinical evaluations were performed, one to assess safety and one to assess performance.

. A worst-case safety test to evaluate the risk of multiple treatments of the same hair was completed. Testing was performed on 44 evaluable subjects with skin types varying from type I - VI. Each subject had three treatment areas, where each hair was treated once, twice, or three times. Treatments were performed at the maximum fluence. Immediate, 24 and 72-hour, one week, and one month post treatment results were assessed by taking a digital photograph and assessing the treatment area for adverse effects. Pain during treatment was also assessed using VAS. All observed responses consisted of, at most, mild erythema and/or mild blistering that spontaneously resolved within 48 hours.

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. An efficacy study was performed on 69 subjects of all skin types (Fitzpatrick scale I-VI). To objectively determine the location and number of hairs, pigmented spots and tattoos, and skin tone, the treatment area was pictured via a dermatoscope by a dermatologist. The dermatologist identified location of hairs and pigments as well as the skin tone to define the "Ground Truth". The study compared the performance of the subject and predicate devices to the objective "Ground Truth" as well as to each other. Subjects received simulated treatments to 6 different areas on the body - legs, arms, face below the nose, underarms, bikini line and chest, consistent with the device's indications. 87 treatment areas were studied in which 25 treatment areas included pigmented spots and 26 treatment areas include tattoos. The subject device has above 90% True Hits and greater number of True Hits than the predicate, and a smaller number of False Hits than the predicate an no Not Safe Hits. The skin tone was also correctly identified in all subjects, validating the skin tone sensor.

Conclusions

The Epilaser Pro has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor differences in technical characteristics do not raise different questions of safety and effectiveness when used as labeled. Performance data demonstrate that the Epilaser Absolute is substantially equivalent to 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.