The InMode Diolaze XL System is intended for hair removal and permanent hair reduction defined as stable, long-term reduction in hair counts at 6,9 or 12 months following a treatment regime.

Device Description

The InMode Diolaze XL device is designed to deliver optical energy to the skin via a pre-cooled 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 hand piece has integrated skin cooling to enhance safety and comfort of the treatment.

The InMode Diolaze XL device consists of an AC/DC power supply unit, a diode driver, water cooling system, controller and a touch screen user interface. The 810nm diode laser hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece comprises the InMode Diolaze XL with 20 diode laser bars stacked vertically. The diode is enclosed to the sapphire light guide. The diode laser produces up to 3000W peak optical power.

AI/ML Overview

The provided FDA 510(k) summary for the InMode Diolaze XL device does not describe acceptance criteria in the context of a study definitively proving the device meets those criteria, nor does it present the results of a clinical study demonstrating performance against such criteria.

Instead, the document details the device's technical specifications and asserts its "substantial equivalence" to a predicate device (Lumenis Ltd. Lightsheer Desire (ET) K151947) based on similarities in intended use, technological characteristics, and compliance with recognized performance standards (non-clinical data).

Therefore, I cannot extract the specific information requested in your prompt as it is not present in the provided text.

Here's a breakdown of what is and is not in the document:

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

Not present for clinical performance. The document provides a table comparing the InMode Diolaze XL's technical specifications (wavelength, fluence, pulse duration, cooling temperature) to the predicate device. It also states the device "operates in accordance with the device design requirements and performs within the range of laser specifications as to that of the predicate device." This is a general statement about non-clinical performance and not specific to clinical acceptance criteria.

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

Not present. No clinical test set or data provenance is mentioned.

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)

Not present. No clinical ground truth establishment is mentioned.

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

Not present. No clinical adjudication method is mentioned.

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

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

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

Not present. This device is a laser for hair removal, not an algorithm.

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

Not present. No clinical ground truth is mentioned. The "ground truth" for showing substantial equivalence appears to be the predicate device's existing clearance.

8. The sample size for the training set

Not present. No training set for an algorithm is mentioned.

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

Not present. No training set for an algorithm is mentioned.

Summary of what the document does provide regarding "performance":

The document focuses on non-clinical performance testing and substantial equivalence.

Non-Clinical Performance Data: The InMode Diolaze XL device's laser output parameters were evaluated for compliance with recognized consensus standards:
- AAMI ANSI: ES 60601-1:2005/(R)2012 and A1:2012. C1:2009/(R)2012 . and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment -Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-2:2007-03(Modified), Medical Electrical Equipment Part 1-● 2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-2-22 Edition 3.1 2012-10, Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1: Edition 2.0 2007-03, Safety of laser products - Part 1: Equipment classification and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)].
Reported performance: "The results of these performance tests demonstrated that the InMode Diolaze XL device operates in accordance with the device design requirements and performs within the range of laser specifications as to that of the predicate device and therefore, is substantially equivalent to the predicate device."
Clinical Performance Data: "Not Applicable" is explicitly stated.

The basis for clearance is demonstrating that the InMode Diolaze XL has similar technological characteristics and the same intended use as a legally marketed predicate device, and that these similarities do not raise different questions of safety and effectiveness. This is typical for a 510(k) submission, especially when clinical data is not deemed necessary due to substantial equivalence.

Summary

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Image /page/0/Picture/2 description: The image shows a partial view of a logo or emblem. The visible portion includes the text "DEPARTMENT OF HEALTH & HUMAN" arranged in a circular fashion, suggesting it's part of a larger circular design. To the right of the text, there's a stylized graphic featuring three abstract profiles facing the same direction, stacked one above the other.

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

August 7, 2017

InMode MD Ltd. % Amit Goren Regulatory Manager A. Stein- Regulatory Affairs Consulting Ltd. 20 Hata'as Str. Suite 102 Kfar Saba. 44425 Israel

Re: K170738 Trade/Device Name: InMode Diolaze XL 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: July 4, 2017 Received: July 10, 2017

Dear Amit Goren:

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

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Jennifer R. Stevenson -S3

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) K170738

Device Name InMode Diolaze XL

Indications for Use (Describe)

The InMode Diolaze XL System is intended for hair removal and permanent hair reduction defined as stable, long-term reduction in hair counts at 6,9 or 12 months following a treatment regime.

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

X 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 XL DEVICE

510(k) Number K170738

Applicant Name:

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

Contact Person:

Official Correspondent: Amit Goren
------------------------------------

Company Name:	A. Stein - Regulatory Affairs Consulting Ltd.
Address:	20 Hata'as Str., Suite 102Kfar Saba 4442500Israel
Tel:	+972-9-7670002
Fax:	+972-9-7668534
E-mail:	amit@asteinrac.com
Date Prepared:	July 04, 2017
Trade Name:	InMode Diolaze XL Device
Classification Name:	CFR Classification section 878.4810; (Product code GEX)
Classification:	Class II Medical Device

Predicate Device:

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

Manufacturer	Device	510(k) No.
Lumenis Ltd.	Lightsheer Desire (ET)	K151947

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Device Description:

Following are the InMode Diolaze XL device specifications:

Laser Output Parameters:

Wavelength	810 nm
Fluence	5-40 J/cm²
Pulse width (duration)	5-200 ms (pulse type : Short/Long)
Light guide cooling	Strong: 7℃, Normal: 12℃
Spot size	11mm x27.5 mm
Dimensions:	46cm W x 46cm D x 100cm H (18.2'' W x 18.2'' D x 40'' H)
Weight:	32 Kg (70.548 lbs)
Main Line Frequency(nominal):	50-60 Hz
Input Voltage (nominal):	100-240 VAC

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Intended Use/Indication for Use:

The InMode Diolaze XL System is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6. 9, or 12 months following a treatment regime.

Performance Standards:

The InMode Diolaze XL Device has been tested and complies with the following voluntary recognized standards:

AAMI ANSI: ES 60601-1:2005/(R)2012 and A1:2012. C1:2009/(R)2012 . and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment -Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2:2007-03(Modified), Medical Electrical Equipment Part 1-● 2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirements and tests
. IEC 60601-2-22 Edition 3.1 2012-10, Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
. IEC 60825-1: Edition 2.0 2007-03, Safety of laser products - Part 1: Equipment classification and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)].

Non-Clinical Performance Data:

The InMode Diolaze XL device laser output parameters were evaluated as part of the test performance evaluation conducted in adherence with the FDA recognized consensus standards 60601-1, 60601-1-2, 60601-2-22 and 60825. The results of these performance tests demonstrated that the InMode Diolaze XL device operates in accordance with the device design requirements and performs within the range of laser specifications as to that of the predicate device and therefore, is substantially equivalent to the predicate device.

Pre-Clinical Performance Data:

Not Applicable

Clinical Performance Data:

Not Applicable

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Substantial Equivalence:

The following table presents a comparison between the subject device and its predicate device:

TechnologicalCharacteristic	InMode Diolaze XLInMode MD Ltd.	LightSheerDesire, ET (LumenisLtd.)K151947
Product Code, Class	GEX,Class II	GEX,Class II
Indications for Use	Hair removal andpermanent hairreduction defined as thestable, long-termreduction in hair countsat 6, 9, or 12 monthsfollowing a treatmentregime.	Hair removal andpermanent hair reductiondefined as the stable, long-term reduction in hairregrowing when measuredat 6, 9, or 12 months afterthe completion oftreatment regime.
Target Population	Subjects seeking hairremoval	Subjects seeking hairremoval
Wavelength	808 nm	805 nm, ET (twohandpiece options areavailable 790-830)
Fluence	5-40 J/cm²	10-100 J/cm²
Pulse duration	5-200 msec	5-400 msec
Coolingtemperature	Skin sapphire cooling	Chilled sapphire tip water-cooled

The indications for use of the InMode Diolaze XL device are substantially equivalent to the indications for use of predicate device and are identical to the indications for use of the InMode Diolaze device (cleared as 510 (k) 142952). The design and components in the InMode Diolaze XL device, including the console (with power supply, software, cooling system and touch screen user interface), the water-cooled hand piece connected to the console via a cable and the foot switch are identical to the design and components found in the InMode Diolaze device (cleared as 510 (k) 142952) and very similar to those of the predicate device. The performance specifications (including wavelength, fluence, pulse width, pulse repetition rate, spot size and cooling) in the InMode Diolaze XL device are very similar to those at the predicate device. The safety features in the InMode Diolaze XL device are substantially equivalent to the safety features found in the predicate device. Consequently, the InMode Diolaze XL device is substantially equivalent to the Lightsheer Desire (ET) predicate device, cleared in 510(k) K151947, and therefore, may be legally marketed in the USA.

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Conclusions:

Based on the performance testing and comparison to predicate device, the InMode Diolaze XL device is as safe and effective as the predicate device and consequently is substantially equivalent to the predicate device and can be sold in the US market.

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.