The InMode Diolaze XL System with the Diolaze XL 810mm Hand piece is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction is hair counts at 6, 9 or 12 months following a treatment regimen. The InMode Diolaze XL System with the Diolaze XL 755/810nm & 810/1064nm Hand pieces is intended for hair removal.

Device Description

The InMode Diolaze XL multisystem (manufactured by InMode MD Ltd.) is a laser based technology platform system utilizing different hand pieces for laser hair removal procedures. The Diolaze XL system was already FDA cleared in K170738 along with its designated Diolaze 810nm hand piece. The InMode Diolaze XL System 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 handpiece has integrated skin cooling to enhance safety and comfort of the treatment. The InMode Diolaze XL System consists of an AC/DC power supply unit, a diode driver, water cooling system, controller and a touch screen user interface. 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 XL System 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. The InMode Diolaze XL System utilizes three add-ons diode laser hand pieces: Diolaze 810nm Hand piece (FDA cleared in K17078), Diolaze 755/810nm Hand piece, Diolaze 810/1064nm Hand piece.

AI/ML Overview

This document describes the FDA 510(k) summary for the InMode Diolaze XL System, a laser device for hair removal. The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and detailed study results as might be found in a clinical trial report.

Here's an analysis of the provided text based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for device performance based on hair reduction percentages. Instead, it relies on demonstrating "significant reduction in hair count" to show efficacy, aligning with the "permanent hair reduction" indication. The performance is compared to the effects observed with predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Hair removal and permanent hair reduction (stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regimen for 810nm handpiece)	"Significant reduction in hair count was demonstrated for both hand pieces and at both treatment areas."
Effective hair removal (for 755/810nm & 810/1064nm handpieces)	An average hair reduction of 49.2% was reached.
No significant safety concerns	"No adverse events were reported in the study."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 31 female subjects.
Data Provenance: The study was "multicenter" but the specific country of origin is not explicitly stated. Given that InMode MD Ltd. is based in Israel, it is plausible the study was conducted there or in another country. The study was prospective, described as a "proscription, open labelled, multicenter, single arm Clinical study."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Three independent, blinded evaluators.
Qualifications of Experts: Not specified. The document only mentions "three independent, blinded evaluators" performed photography hair counts.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated, but implies a consensus or averaging approach: "Photography hair counts were performed by three independent, blinded evaluators and a statistical comparison was conducted..." It does not specify if disagreements were resolved through additional review (like 2+1 or 3+1) or if an average or majority vote was used.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not Applicable. The described study is a single-arm clinical study evaluating the device's efficacy, not a comparative effectiveness study involving human readers with and without AI assistance. The device itself is a laser hair removal system, not an AI-powered diagnostic or assistive tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not Applicable. This is a hardware medical device (laser system), not a software algorithm. The "performance" being evaluated is hair reduction on human subjects.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for hair reduction efficacy was established using photography hair counts performed by independent evaluators, compared to baseline. This can be considered a form of expert consensus/objective measurement based on photographic evidence.

8. Sample Size for the Training Set

Not Applicable. The device is a laser system and does not involve AI or machine learning algorithms that would typically require a "training set" for model development. The software validation mentioned (IEC 62304) pertains to the safety and functionality of the device's operating software, not to an AI model trained on data.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no AI/ML algorithm requiring a training set, this question is not relevant to the provided information.

Summary

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June 14, 2018

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

Re: K180719

Trade/Device Name: InMode Diolaze System 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: March 12, 2018 Received: March 19, 2018

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, 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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Jennifer R. Stevenson -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K180719

Device Name

InMode Diolaze XL System

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 XL SYSTEM

510(k) Number K180719

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:	March 12, 2018
Trade Name:	InMode Diolaze XL System
Classification Name:	CFR Classification section 878.4810; (Product code GEX)
Classification:	Class II Medical Device

Predicate Device:

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

Manufacturer	Device	510(k) No.
Asceplion Laser Technologies GmbH	MedioStar NeXT Family (ALX)	K143519
InMode MD Ltd.	InMode Diolaze XL	K170738
Lutronics Corp.	Advantage	K141555

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Device Description:

The InMode Diolaze XL System 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 handpiece has integrated skin cooling to enhance safety and comfort of the treatment.

The InMode Diolaze XL System consists of an AC/DC power supply unit, a diode driver, water cooling system, controller and a touch screen user interface. 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 XL System 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.

The InMode Diolaze XL System utilizes three add-ons diode laser hand pieces:

Diolaze 810nm Hand piece (FDA cleared in K170738)
Diolaze 755/810nm Hand piece ●
Diolaze 810/1064nm Hand piece .

Following are the InMode Diolaze XL System specifications:

Laser Output Parameters:
Wavelengths	810 nm810/1064 nm755/810 nm
Fluence	5-40 J/cm²
Pulse width (duration)	5-200 ms (pulse type : Short/Long)
Light guide cooling	Strong: 7°C, Normal: 12°C
Spot size	11x 27.5 mm²
Dimension:	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 with the Diolaze XL 810mm Hand piece 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.

The InMode Diolaze XL System with the Diolaze XL 755/810nm & 810/1064nm Hand pieces is intended for hair removal.

Performance Standards:

The InMode Diolaze XL System 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 System 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 60825-1. The results of these performance tests demonstrated that the InMode Diolaze XL System operates in accordance with the device design requirements and performs within the range of laser specifications as to that of the predicate devices and therefore, is substantially equivalent to the predicate devices. Additionally, the device SW was validated in accordance with the FDA recognized consensus standard IEC 62304:2004 to IEC 62304 — 2006/AC 2008.

Pre-Clinical Performance Data:

Not Applicable

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Clinical Performance Data:

A proscription, open labeled, multicenter, single arm Clinical study was conducted to evaluate the efficacy and safety of the InMode Diolaze XL System with the Diolaze 755/810nm and 810/1064nm hand pieces. The study performed on 31 female subjects, aged between 18-65 years old, comprise three consecutive hair removal laser treatment, 4 weeks apart, and a follow up visit scheduled 3months from last laser treatment. The subjects were treated on their axilla, and groin areas with either the 755/810nm hand piece or the 810/1064nm hand piece. The treatment area was photographed following treatment and at follow up visit. Photography hair counts were performed by three independent, blinded evaluators and a statistical comparison was conducted between baseline hair counts and 3 months follow up hair counts. Study results revealed that a significant reduction in hair count was demonstrated for both hand pieces and at both treatment areas. An average hair reduction of 49.2% was reached. No adverse events were reported in the study.

Substantial Equivalence:

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

TechnologicalCharacteristic	InMode DiolazeXL SystemInMode MDLtd.	InMode DiolazeXL System(InMode MDLtd.)K170738	Advantage(LutronicsCorp.)K141555	MedioStar, ALX(Asceplion LaserTechnologies GmbH)K143519
ProductCode, Class	GEX,Class II	GEX,Class II	GEX,Class II	GEX,Class II
Indicationsfor Use	The InModeDiolaze XLSystem with theDiolaze XL810nm Handpiece is intendedfor hair removaland permanenthair reductiondefined as thestable, long-termreduction in haircounts at 6, 9, or12 monthsfollowing atreatmentregime.	Hair removal andpermanent hairreduction definedas the stable,long-termreduction in hairregrowing whenmeasured at 6, 9,or 12 monthsafter thecompletion oftreatment regime.	Is intendedfor hairremoval,permanenthairreduction(defined aslong termstablereduction inthe numberof hairsregrowingafter the lasttreatmentmeasured at6,9 and 12months	Hair removal andpermanent hairreduction defined asreduced growth withor withoutmaintenance whenmeasured at 6, 9, or 12months

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TechnologicalCharacteristic	InMode DiolazeXL SystemInMode MDLtd.	InMode DiolazeXL System(InMode MDLtd.)K170738	Advantage(LutronicsCorp.)K141555	MedioStar, ALX(Asceplion LaserTechnologies GmbH)K143519
	Diolaze XLSystem with theDiolaze XL755/810nm &810/1064nmHand pieces isintended for hairremoval.
TargetPopulation	Subjects seekinghair removal	Subjects seekinghair removal	Subjectsseeking hairremoval	Subjects seeking hairremoval
Wavelength	810 nm810/1064 nm755/810 nm	810nm	1064 nm	755 nm, ALX (severalhand pieces areavailable as an optionthat are 755-950nm))
Fluence	5-40 J/cm²	5-40 J/cm²	5-100 J/cm²	Maximum fluence:35 J/cm²
Pulseduration	5-200 msec	5-200 msec	5-400 msec	Max pulse duration:400 msec
Coolingtemperature	Skin sapphirecooling	Skin sapphirecooling	Contactcoolingchilledcompressiontip	Skin cooling: Contactskin cooling by coldaluminum probe(chilled compressiontip). Integrated watercompressor coolingsystem
Spot size	11x27.5mm²	11x27.5mm²	10x10mm²	13x10mm²

The indications for use of the InMode Diolaze XL System are substantially equivalent to the indications for use of predicate devices and are identical to the indications for use of the InMode Diolaze XL device (cleared as 510 (k) 170738). The design and components in the InMode Diolaze XL System, 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) 170738) and very similar to those of the predicate devices. The performance specifications (including wavelength, fluence, pulse width, spot size and cooling) in the InMode Diolaze XL System are very similar to the predicate devices. The safety features in the InMode Diolaze XL System are substantially equivalent to the safety features found in the predicate devices. Consequently, the InMode Diolaze XL System is substantially equivalent to the MedioStar NeXT Family (ALX) predicate device, cleared in 510(k) K143519, the InMode Diolaze XL System predicate device, cleared in 510(k) K170738,

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and to the Advantage predicate device, cleared in 510 (k) K141555 and therefore, may be legally marketed in the USA.

Conclusions:

Based on the performance testing, clinical study and comparison to predicate devices, the InMode Diolaze XL System is as safe and effective as its predicate devices and consequently 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.