The InMode Diolaze device is indicated for use for hair removal and for permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Device Description

The InMode Diolaze device is designed to deliver optical energy to the skin via a precooled sapphire block. The good optical contact between the 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 of the InMode Diolaze device 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 Diolaze 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 Diolaze device 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 the hand piece to the console via a connector.

AI/ML Overview

This document is a 510(k) Pre-Market Notification from the FDA regarding the InMode Diolaze Device. It addresses the device's substantial equivalence to other legally marketed devices, primarily for hair removal and permanent reduction in hair regrowth.

Based on the provided text, the InMode Diolaze Device did not undergo a clinical study to prove its performance against acceptance criteria. Instead, its acceptance was based on non-clinical performance data and substantial equivalence to previously cleared predicate devices.

Therefore, the following information cannot be extracted from the document:

A table of acceptance criteria and the reported device performance: No specific performance acceptance criteria related to a clinical outcome are described, nor are clinical performance results provided. The acceptance concerned the device's technical specifications and safety matching those of predicate devices.
Sample sizes used for the test set and the data provenance: No test set of clinical data was used; the evaluation was based on comparisons to predicate device specifications.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth was established through expert review of clinical data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical test set was used.
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: Not applicable. This device is a laser for hair removal, not an AI for image interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No clinical ground truth was used. The "ground truth" for substantial equivalence was the established specifications and safety profile of the predicate devices.
The sample size for the training set: Not applicable as no machine learning model was developed or trained for this device.
How the ground truth for the training set was established: Not applicable.

Summary of Device Acceptance and Study Justification (based on the provided text):

The InMode Diolaze Device's acceptance by the FDA was based on its substantial equivalence to existing, legally marketed predicate devices. This approach, common for 510(k) submissions, means the device was determined to be as safe and effective as a predicate device and did not require new clinical performance data.

The justification for this substantial equivalence included:

Identical Design and Components: The InMode Diolaze device is described as identical to the InMode Hair Removal (HR) device (K123682) in its console, handpiece, and foot switch. It is also similar in design and components to the Leda EPI 808 (K090762) predicate device.
Identical/Similar Performance Specifications: The device's performance specifications (wavelength, fluence, pulse width, pulse repetition rate, spot size, and cooling) are stated to be identical to the InMode HR device and similar to the Leda EPI 808.
Identical/Equivalent Safety Features: The safety features are deemed substantially equivalent to the predicate devices.
Non-Clinical Performance Data: Bench tests were conducted on the InMode Hair Removal (HR) device (which is stated to be the same device as the InMode Diolaze) to compare its laser output parameters to those of the Leda EPI 808 predicate device. These tests demonstrated that the InMode HR device (and thus the Diolaze) has the same laser output specifications as the predicate.
Adherence to Standards: The device complies with relevant IEC standards for medical electrical equipment, safety of laser products, and particular requirements for surgical, cosmetic, therapeutic, and diagnostic laser equipment.

A dedicated clinical study (as would be typical for proving performance against specific clinical acceptance criteria for novel devices) was explicitly stated as "Not Applicable" for this 510(k) submission. The core of the acceptance was the demonstration that the InMode Diolaze product possesses the same fundamental technology, specifications, and safety profile as already cleared devices, making it "substantially equivalent."

Summary

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

January 13, 2015

Inmode Md Ltd. % Ahava Stein Regulatory Manager A. Stein-Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, 4442520 Israel

Re: K142952 Trade/Device Name: Inmode Diolaze Device 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 19, 2014 Received: November 24, 2014

Dear Ahava Stein.

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 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 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) K142952

Device Name InMode Diolaze Device

Indications for Use (Describe)

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)

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510(K) SUMMARY

INMODE DIOLAZE DEVICE

510(k) Number K_______________________________________________________________________________________________________________________________________________________________

Applicant Name:

Company Name:	InMode MD Ltd.
Address:	Tabor Building, Shaar YokneamYokneam 2069200Israel
	Tel: +972-4-9097470
	Fax: +972-4-9097471
	E-mail: ahava@asteinrac.com

Contact Person:

Official Correspondent:	Ahava Stein
Company Name:	A. Stein - Regulatory Affairs Consulting Ltd.
Address:	20 Hata'as Str., Suite 102Kfar Saba 4442500IsraelTel: +972-9-7670002Fax: +972-9-7668534E-mail: ahava@asteinrac.com
Date Prepared:	October 07, 2014
Trade Name:	InMode Diolaze Device
Classification Name:	CFR Classification section 878.4810; (Product code GEX)
Classification:	Class II Medical Device

Predicate Device:

The InMode Diolaze device is substantially equivalent to the following predicate devices.

Manufacturer	Device	510(k) No.
InMode MD Ltd.	InMode Hair Removal (HR) Device	K123682
Quantel Derma GmbH	Leda EPI 808	K090762

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Device Description:

Intended Use/Indication for Use:

Performance Standards:

The InMode Diolaze device is identical to the InMode Hair Removal (HR) device (same device). Therefore, the InMode Diolaze device complies with the voluntary performance standards listed below in which the InMode Hair Removal (HR) device was tested and complies with:

. IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995
o IEC 60601-1-2. (Third Edition, 2007), 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; (2001)

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IEC 60601-2-22 Medical Electrical Equipment Part 2-22: Particular o requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment (1995)

Non-Clinical Performance Data:

The InMode Diolaze device is identical to the InMode Hair Removal (HR) device (same device), as such, for this 510k submission the same performance test documents used for K123682 are provided comparing the InMode Hair Removal (HR) device laser output parameters to those of the Leda EPI 808 predicate device. The results of the bench tests demonstrate that the InMode HR device has the same laser output specifications as the predicate Leda EPI 808 device and along with the fact that the InMode Diolaze device is identical to the InMode Hair Removal device, it can be concluded that the InMode Diolaze device is substantially equivalent to the predicate devices.

Clinical Performance Data:

Not Applicable

Substantial Equivalence:

The indications for use of the InMode Diolaze device are substantially equivalent to the indications for use of the Leda EPI 808 predicate device and are an expansion of the indications for use of the InMode Hair Removal (HR) device with the permanent reduction in hair regrowth indication. The design and components in the InMode Diolaze 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 identical to the design and components found in the InMode Hair Removal (HR) (same device) and similar to the Leda EPI 808 predicate devices. The performance specifications (including wavelength, fluence, pulse width, pulse repetition rate, spot size and cooling) in the InMode Diolaze device are identical to performance specifications in the InMode Hair Removal (HR) and similar to the Leda EPI 808 predicate device. The safety features in the InMode Diolaze device are substantially equivalent to the safety features found in the predicate devices. Consequently, the InMode Diolaze device is substantially equivalent to the InMode Hair Removal (HR) predicate device, cleared in 510(k) K123682, and to the Leda EPI 808 predicate device, cleared in 510(k) K090762, and therefore, may be legally marketed in the USA.

Conclusions:

Based on the performance testing and comparison to predicate devices, the InMode Diolaze device is substantially equivalent to the predicate devices listed above.

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.