InMode Diolaze System

K180719 · Inmode MD , Ltd. · GEX · Jun 14, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K180719
• Device Name: InMode Diolaze System
• Applicant: Inmode MD , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 14, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Laser-based platform for hair removal; utilizes diode laser handpieces (810nm, 755/810nm, 810/1064nm) to deliver optical energy to skin. System includes console with AC/DC power supply, diode driver, water cooling, controller, and touch screen interface. Handpieces feature integrated sapphire block cooling to enhance patient comfort. Operated by clinician in clinical setting; energy delivery activated via footswitch. Clinician adjusts light fluence and pulse duration based on patient needs. Optical energy targets hair follicles; cooling protects skin surface. Benefits include efficient hair removal/reduction. Output is laser energy; clinician monitors treatment via interface and visual inspection of skin.

Clinical Evidence

Prospective, open-label, multicenter, single-arm study. 31 female subjects (18-65 years). Three laser treatments (4 weeks apart) on axilla and groin using 755/810nm or 810/1064nm handpieces. Primary endpoint: hair count reduction at 3-month follow-up vs baseline. Results: 49.2% average hair reduction. No adverse events reported.

Technological Characteristics

Diode laser system; wavelengths 810nm, 755/810nm, 810/1064nm. Fluence 5-40 J/cm²; pulse width 5-200 ms. Sapphire block contact cooling (7°C/12°C). 20 diode laser bars per handpiece. Standards: AAMI ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1. Software validated per IEC 62304.

Indications for Use

Indicated for hair removal and permanent hair reduction in patients seeking hair removal. No specific contraindications listed.

Regulatory Classification

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.

Predicate Devices

• MedioStar NeXT Family (ALX) (K143519)
• InMode Diolaze XL (K170738)
• Advantage (K141555)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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 Yokneam<br>Yokneam 2069200<br>Israel |
| Tel: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |

## Contact Person:

Official Correspondent: Amit Goren

| Company Name: | A. Stein - Regulatory Affairs Consulting Ltd. | | |
|----------------------|-----------------------------------------------------------|--|--|
| Address: | 20 Hata'as Str., Suite 102<br>Kfar Saba 4442500<br>Israel | | |
| | | | |
| | | | |
| | | | |
| | | | |
| Tel: | [phone] | | |
| Fax: | [phone] | | |
| E-mail: | [e-mail] | | |
| 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 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 K170738)
- Diolaze 755/810nm Hand piece ●
- Diolaze 810/1064nm Hand piece .

Following are the InMode Diolaze XL System specifications:

| Laser Output Parameters: | |
|--------------------------------|----------------------------------------------------------|
| Wavelengths | 810 nm<br>810/1064 nm<br>755/810 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<br>(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:

| Technological<br>Characteristic | InMode Diolaze<br>XL System<br>InMode MD<br>Ltd. | InMode Diolaze<br>XL System<br>(InMode MD<br>Ltd.)<br>K170738 | Advantage<br>(Lutronics<br>Corp.)<br>K141555 | MedioStar, ALX<br>(Asceplion Laser<br>Technologies GmbH)<br>K143519 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>Code, Class | GEX,<br>Class II | GEX,<br>Class II | GEX,<br>Class II | GEX,<br>Class II |
| Indications<br>for Use | The InMode<br>Diolaze XL<br>System with the<br>Diolaze XL<br>810nm Hand<br>piece is intended<br>for hair removal<br>and permanent<br>hair reduction<br>defined as the<br>stable, long-term<br>reduction in hair<br>counts at 6, 9, or<br>12 months<br>following a<br>treatment<br>regime. | Hair removal and<br>permanent hair<br>reduction defined<br>as the stable,<br>long-term<br>reduction in hair<br>regrowing when<br>measured at 6, 9,<br>or 12 months<br>after the<br>completion of<br>treatment regime. | Is intended<br>for hair<br>removal,<br>permanent<br>hair<br>reduction<br>(defined as<br>long term<br>stable<br>reduction in<br>the number<br>of hairs<br>regrowing<br>after the last<br>treatment<br>measured at<br>6,9 and 12<br>months | Hair removal and<br>permanent hair<br>reduction defined as<br>reduced growth with<br>or without<br>maintenance when<br>measured at 6, 9, or 12<br>months |

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| Technological<br>Characteristic | InMode Diolaze<br>XL System<br>InMode MD<br>Ltd. | InMode Diolaze<br>XL System<br>(InMode MD<br>Ltd.)<br>K170738 | Advantage<br>(Lutronics<br>Corp.)<br>K141555 | MedioStar, ALX<br>(Asceplion Laser<br>Technologies GmbH)<br>K143519 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| | Diolaze XL<br>System with the<br>Diolaze XL<br>755/810nm &<br>810/1064nm<br>Hand pieces is<br>intended for hair<br>removal. | | | |
| Target<br>Population | Subjects seeking<br>hair removal | Subjects seeking<br>hair removal | Subjects<br>seeking hair<br>removal | Subjects seeking hair<br>removal |
| Wavelength | 810 nm<br>810/1064 nm<br>755/810 nm | 810nm | 1064 nm | 755 nm, ALX (several<br>hand pieces are<br>available as an option<br>that are 755-950nm)) |
| Fluence | 5-40 J/cm² | 5-40 J/cm² | 5-100 J/cm² | Maximum fluence:<br>35 J/cm² |
| Pulse<br>duration | 5-200 msec | 5-200 msec | 5-400 msec | Max pulse duration:<br>400 msec |
| Cooling<br>temperature | Skin sapphire<br>cooling | Skin sapphire<br>cooling | Contact<br>cooling<br>chilled<br>compression<br>tip | Skin cooling: Contact<br>skin cooling by cold<br>aluminum probe<br>(chilled compression<br>tip). Integrated water<br>compressor cooling<br>system |
| 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.