The InMode Hair Removal (HR) device is designed to deliver optical energy to the skin via a pre-cooled sapphire block. The good optical contact between sapphire block and skin is achieved by using water based gel. The device provides individual adjustment of light fluence and pulse duration to achieve maximum efficiency and safety for each patient. The scanning system embedded into the laser InMode HR hand piece allows efficient treatment with less risk of overlap. The hand piece has integrated skin cooling to enhance safety and comfort of the treatment.

The InMode Hair Removal device consists of an AC/DC power supply unit, a diode driver, water cooling system, controller and user interface including an LCD screen and functional buttons. The diode laser hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises the InMode HR laser with linear scanning system, cooled sapphire output window (8 x 50mm), and electronic shutter.

The sapphire light guide is located on the front tip of the hand piece and delivers the laser beam energy to the treated tissue, while cooling the skin. The pair of thermoelectric coolers (TECs) located on both sides of the sapphire block provide cooling to a temperature of 4°C. The hand piece contains a trigger button which starts the laser scan and radiation. Fluence (light energy density) is delivered within the limits of 10 to 60J/cm2. The hand piece has a cable that is 170cm long and connects to the hand piece to the console via a connector.

AI/ML Overview

The manufacturer, InMode MD Ltd., states that the InMode Hair Removal (HR) device is substantially equivalent to two predicate devices: Lumenis Ltd.'s LightSheer (K001746) and Quantel Derma GmbH's Leda EPI 808 (K090762). Therefore, the acceptance criteria for the InMode Hair Removal (HR) device are based on demonstrating its equivalence to these predicate devices in terms of design, performance, and safety.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Acceptance Criteria (Demonstrates equivalence to predicate devices)	Reported Device Performance (InMode Hair Removal (HR) device)
Intended Use/Indications for Use	Same as predicate devices for hair removal.	Indicated for use for hair removal, same as predicate devices.
Design and Components	Similar to predicate devices (console with power supply, software, cooling system, touch screen UI; water-cooled hand piece with cable/connector; foot switch).	Similar design and components to predicate devices.
Performance Specifications	Similar wavelength, fluence, pulse width, pulse repetition rate, spot size, and cooling as predicate devices (LightSheer and Leda EPI 808).	Similar performance specifications (wavelength, fluence, pulse width, pulse repetition rate, spot size, cooling) to predicate devices. Bench tests showed `same laser output specifications` as Leda EPI 808.
Safety Features	Substantially equivalent to safety features in predicate devices.	Safety features substantially equivalent to predicate devices. Device complies with IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, and IEC 60601-1-4.
Software and Specifications	Any minor differences meet system requirements and do not raise new safety or effectiveness concerns.	Performance tests demonstrated that minor differences meet system requirements and do not raise new safety or effectiveness concerns.

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

Test set sample size: Not applicable for a human subject test set. The document describes non-clinical bench testing.
Data provenance: Not explicitly stated for specific data points, but the testing was conducted by InMode MD Ltd.

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

Not applicable as this was a non-clinical bench test comparing output parameters, not a clinical study requiring expert ground truth for efficacy.

4. Adjudication method for the test set:

Not applicable. The "test set" refers to bench testing to compare device parameters, not a clinical trial requiring adjudication of outcomes.

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. This device is a hair removal laser, not an AI-assisted diagnostic tool.

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

The performance assessment focused on the device's technical specifications and safety compliance. "Clinical Performance Data: Not Applicable" is explicitly stated. Therefore, a standalone algorithm performance study (as would be relevant for software/AI) was not performed. The performance evaluation was based on bench testing of the physical device's output parameters.

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

For the non-clinical performance data, the "ground truth" was established by the specified laser output parameters of the predicate devices (Leda EPI 808) and compliance with various international safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, IEC 60601-1-4).

8. The sample size for the training set:

Not applicable. This device is a laser system, not a machine learning algorithm that requires a training set.

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

Not applicable, as there was no training set for a machine learning algorithm.

Summary

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FEB 27 2013

510(K) SUMMARY

INMODE HAIR REMOVAL (HR) DEVICE

510(k) Number K 123682

Applicant Name:

Company Name: Address:

InMode MD Ltd. Tabor Building, Shaar Yokneam Yokneam 20692 Israel Tel: +972-4-9097470 Fax: +972-4-9097471 E-mail: ahava@asteinrac.com

Contact Person:

Official Correspondent: Ahava Stein

Company Name: Address:

· A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba 44425 Israel Tel: +972-9-7670002 Fax: +972-9-7668534 E-mail: ahava@asteinrac.com

November, 25, 2012 Date Prepared:

InMode Hair Removal (HR) Device Trade Name:

Classification Name: CFR Classification section 878.4810; (Product code GEX)

Classification: Class II Medical Device

Predicate Device:

The InMode Hair Removal (HR) device is substantially equivalent to the following predicate devices.

Manufacturer	Device	510(k) No.
Lumenis Ltd., formerly StarMedical/Coherent	LightSheer	K001746
Quantel Derma GmbH	Leda EPI 808	K090762

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Device Description:

Intended Use/Indication for Use:

The InMode Hair Removal (HR) device is indicated for use for hair removal.

Performance Standards:

The InMode Hair Removal (HR) Device has been tested and complies with the following voluntary recognized standards:

IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for ● Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995
IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment Part 1-. 2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests
IEC 60825-1 Safety of laser products, Part 1: Equipment classification and . requirements;
IEC 60601-2-22 Medical Electrical Equipment Part 2-22: Particular . requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment;
IEC 60601-1-4 Medical electrical equipment Part 1-4:General requirements for safety - Collateral Standard: Programmable electrical medical systems

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Non-Clinical Performance Data:

Additionally, bench tests were conducted comparing the InMode Hair Removal (HR) device laser output parameters to those of the Leda EPI 808 predicate device. The results of the bench test demonstrate that the InMode HR device has the same laser output specifications as the predicate Leda EPI 808 device and therefore, is substantially equivalent to the predicate device.

Clinical Performance Data:

Not Applicable

Substantial Equivalence:

The indications for use of the InMode Hair Removal (HR) device are substantially equivalent to the indications for use of the LightSheer and the Leda EPI 808 predicate devices. The design and components in the InMode Hair Removal (HR) device, including the console (with power supply, software, cooling system and touch screen user interface), the water-cooled hand piece (with cable and connector to console) and the foot switch are similar to the design and components found in the LightSheer and Leda EPI 808 predicate devices. The performance specifications (including wavelength; fluence, pulse width, pulse repetition rate, spot size and cooling) in InMode Hair Removal (HR) device are similar to performance specifications in the LightSheer and Leda EPI 808 predicate devices. These safety features in the InMode Hair Removal (HR) device are substantially equivalent to the safety features found in the predicate devices. The performance tests demonstrated that any minor differences in the device software and specifications meet the system requirements and do not raise new safety or effectiveness concerns. Consequently, the InMode Hair Removal (HR) device is substantially equivalent to the LightSheer predicate device, cleared under 510(k) K001746, and to the Leda. EPI 808 predicate device, cleared in 510(k) submission K090762, and therefore, may be legally marketed in the USA.

Conclusions:

Based on the performance testing and comparison to predicate devices, the InMode Hair Removal (HR) device is substantially equivalent to the predicate devices listed above.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and 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 an abstract symbol that resembles a stylized caduceus or a bird-like figure with three curved lines representing wings or streams.

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

Inmode Hair Removal (HR) Device % A.Stein-Regulatory Affairs Consulting, Limited Ahava Stein Regulatory Manager 20 Hata'as Street, Suite 102 Kfar Saba, Israel 44425

Re: K123682

Trade/Device Name: InMode Hair Removal (HR) 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: November 27, 2012 Received: November 30, 2012

Dear Ahava Stein:

We have reviewed vour 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

February 27, 2013

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Page 2 - Ahava Stein

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers. International and Consumer Assistance 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,

For

PeterD.Rumm-S

Mark N. Melkerson Acting 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): K123682

InMode Hair Removal (HR) Device Name:

Intended Use Statement:

The InMode Hair Removal (HR) device is indicated for use for hair removal.

V Over-The-Counter Use Prescription Use ાર (Per 21 C.F.R. 801 Subpart D) (Optional Format Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden 2013.02.27 09:32:05 -05'00'

Division of Surgical Devices
510(k) Number K123682

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.