InMode Multi-system
Device Facts
| Record ID | K221571 |
|---|---|
| Device Name | InMode Multi-system |
| Applicant | InMode , Ltd. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Jun 30, 2022 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The InMode Multi System with the Diode laser Applicators is indicated for: · Diolaze XL 810nm Applicator 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. · Diolaze XL 755/810nm & 810/1064nm Applicators are intended for hair removal. · VLaze Applicator is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions. The InMode Multi System with the IPL Applicator is indicated for: • IPL Applicator with wavelengths (515-1200mm) is indicated for use for the following treatments: The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikilodenna of Civatte, superficial leg veins and venlous malformations. The InMode Multi System with the non-invasive RF Applicators is indicated for: · BodyFX (WMBody) and MiniFX Applicators are intended for the tollowing medical conditions: Relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation; and temporary reduction in the appearance of cellulite. · PLUS/ PLUS90/PLUS-PLUS (FORMA) and i-Forma Applicators are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. · FaceFX (WMFace) Applicator is intended for use in dermatologic procedures, for noninvasive treatment of mild to moderate facial wrinkles and rhytids. The InMode Multi System with the Fractional RF Applicators is indicated for: · FRACTORA 60 pin Applicator is intended for use in dermatological procedures requiring ablation and resurfacing of the skin. · FRF 24 pin Applicator is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. · Fractora3D and Morpheus8 Applicators are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62 m.V.pin, use is limited to Skin Types I-V.
Device Story
InMode Multi-system is a line-powered, software-controlled platform for aesthetic and surgical procedures. It delivers controlled radiofrequency (RF), laser, or IPL energy via interchangeable applicators. Used in hospitals or clinics by trained professionals. Input: user-selected energy parameters via 12" LCD touch screen. Transformation: system platform drives specific applicators (Diolaze XL, VLaze, IPL, BodyFX, MiniFX, Forma, Fractora, Morpheus8) to deliver energy to target tissue. Output: thermal or ablative energy for tissue treatment. Clinical decision-making: provider selects applicator and energy settings based on patient condition (e.g., hair removal, vascular lesions, skin resurfacing). Benefits: non-invasive or minimally invasive treatment of dermatologic conditions, muscle pain relief, and skin rejuvenation.
Clinical Evidence
No clinical data. Substantial equivalence is supported by bench testing, including software validation, electrical and mechanical safety testing, electromagnetic compatibility testing, and specific testing for RF and laser technologies.
Technological Characteristics
Line-powered platform; 100-240 VAC, 50-60 Hz. Energy sources: Diode laser (755/810/1064nm), IPL (515-1200nm), and 1 MHz RF. Dimensions: 46cm x 46cm x 100cm; Weight: 32kg. Features water cooling system, footswitch, and 12" LCD interface. Applicators are Gamma sterilized (tips) or reusable (handles). Software-controlled with RF measuring circuit.
Indications for Use
Indicated for adults requiring dermatologic or general surgical procedures including hair removal/reduction, treatment of vascular/pigmented lesions, relief of muscle aches/spasms, improvement of local circulation, cellulite reduction, wrinkle treatment, skin ablation/resurfacing, and electrocoagulation/hemostasis.
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
- InMode System (K180719)
- VLaze (K173677)
- SR IPL (K123860)
- FRACTORA 60 Pin (K102461)
- InMode FRF 24 Pin (K151273)
- Fractora3D (K180189)
- Morpheus8 (K200947)
- BodyFX (WMBody) (K131362)
- MiniFX (K160329)
- Forma (Plus), Plus90 and Plus (Plus-Plus) (K172302)
- i-Forma (K210492)
- WMFace (K140926)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
June 30, 2022
InMode Ltd. % Amit Goren Regulatory Consultant A. Stein-Regulatory Affairs Consulting Ltd. 18 Hata'as Str., Sute 21 Kfar Saba, 4442518 Israel
Re: K221571
Trade/Device Name: InMode Multi-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, GEI, ONF, NUV, ISA, PBX Dated: May 26, 2022 Received: May 31, 2022
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 and Part 809 medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known)
K221571 Device Name InMode Multi System
Indications for Use (Describe)
The InMode Multi System with the Diode laser Applicators is indicated for:
· Diolaze XL 810nm Applicator 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.
· Diolaze XL 755/810nm & 810/1064nm Applicators are intended for hair removal.
· VLaze Applicator is intended for the treatment of vascular lesions, including
angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.
The InMode Multi System with the IPL Applicator is indicated for:
• IPL Applicator with wavelengths (515-1200mm) is indicated for use for the following treatments: The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikilodenna of Civatte, superficial leg veins and venlous malformations.
The InMode Multi System with the non-invasive RF Applicators is indicated for:
· BodyFX (WMBody) and MiniFX Applicators are intended for the tollowing medical conditions: Relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation; and temporary reduction in the appearance of cellulite.
· PLUS/ PLUS90/PLUS-PLUS (FORMA) and i-Forma Applicators are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
· FaceFX (WMFace) Applicator is intended for use in dermatologic procedures, for noninvasive treatment of mild to moderate facial wrinkles and rhytids.
The InMode Multi System with the Fractional RF Applicators is indicated for:
· FRACTORA 60 pin Applicator is intended for use in dermatological procedures requiring ablation and resurfacing of the skin.
· FRF 24 pin Applicator is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
· Fractora3D and Morpheus8 Applicators are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62 m.V.pin, use is limited to Skin Types I-V.
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)
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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#### 510(K) SUMMARY
# INMODE MULTI SYSTEM
### 510(k) Number K221571
| Applicant Name: | InMode Ltd. |
|-----------------|---------------------------------------|
| Company Name: | Tabor Building, Shaar Yokneam POB 44, |
| Address: | Yokneam Iillit, 2069200 Israel |
| | 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: | 18 Hata'as Str.,<br>Kfar Saba 4442518, Israel<br>Tel: +972-9-7670002<br>Fax: +972-9-7668534<br>E-mail: amit@asteinrac.com |
Date Prepared: May 26, 2022
InMode Multi System Trade Name:
# Classification Name: Main system platform:
21 CFR 878.4810, Class II, GEX System Applicators:
21 CFR 878.4810, Class II, GEX
21 CFR 878.4810, Class II, ONF
21 CFR 878.4810, Class II, NUV
- 21 CFR 878.4810, Class II, ISA
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21 CFR 878.4400, Class II, GEI 21 CFR 878.4400, Class II, PBX
## Classification: Class II Medical Device
### Predicate Device:
The subject device is substantially equivalent to the following predicate device:
| Subject Device<br>Component | Regulation<br>Number | Product<br>Code | Primary/Secondary<br>predicate device | Predicate<br>device 510(K)<br>number |
|------------------------------------------------------------------------------------------------------------------------|----------------------|-----------------|---------------------------------------|---------------------------------------------|
| Main platform/<br>Console | 878.4810 | GEX | Primary | K180719 |
| Diolaze XL | 878.4810 | GEX | Secondary | K180719 |
| VLaze | 878.4810 | GEX | Secondary | K173677 |
| SR IPL | 878.4810 | ONF | Secondary | K123860 |
| Fractional RF<br>Applicators:<br>FRACTORA 60<br>Pin, InMode FRF<br>24 Pin,<br>Morpheus8,<br>FRACTORA 3D<br>Applicators | 878.4810 | GEI | Secondary | K200947,<br>K180189,<br>K151273,<br>K102461 |
| BodyFX<br>(WMBody)<br>Applicator | 878.4810<br>890.5560 | NUV,<br>ISA | Secondary | K131362 |
| MiniFX<br>Applicator | 878.4400<br>890.5560 | GEI,<br>ISA | Secondary | K160329 |
| Forma (Plus),<br>Plus90 and Plus<br>(Plus-Plus)<br>Applicators | 878.4400<br>890.5560 | PBX,<br>ISA | Secondary | K172302 |
| i-Forma<br>Applicator | 878.4400<br>890.5560 | PBX,<br>ISA | Secondary | K210492 |
| WMFace<br>Applicator | 878.4400 | GEI, | Secondary | K140926 |
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## Device Description:
The InMode Multi-System supports multiple technological applications and accessories intended for different clinical indications. The subject device is designed to exert finely controlled radiofrequency, laser or IPL energy utilizing different treatment applicators. The subject device comprises a system platform and compatible set of applicators. The system platform was originally FDA Cleared in K180719 and is manufactured by InMode Ltd.
The subject device platform sustains additional FDA Cleared applicators, all manufactured by InMode Ltd.
The below list comprises the set of applicators to be registered under the subject device:
- . Laser Applicators:
- o Diolaze XL 810nm
- Diolaze XL 755/810nm o
- Diolaze XL 810/1064nm o
- VLaze (Vasculaze) о
- IPL Applicator: ●
- o SR IPL (Lumecca 580, Lumecca 515)
- Non-Invasive RF Applicators: ●
- o Forma (Plus)
- Plus (Plus Plus) о
- Plus90 o
- о i-Forma
- BodyFX™ (WMBody) o
- MiniFXTM o
- WMFace o
- Fractional RF Applicators: ●
- Fractora o
- 24 pins tip (FRF) -
- । 60 pins tip
- 0 Morpheus8TM
- 12 pins tip (Prime Tip) -
- 24 pins tip (Fractora 3D) -
- 40 pins tip (Body Tip) -
- T tip -
The platform of the subject device has undergone some slight design modifications, mainly in software, to support the integration of the abovementioned applicators.
Slight modifications were also performed on platform hardware for the same purpose.
Additionally, the user interface screen was slightly enlarged from 10" to 12".
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The abovementioned modifications have no significant influence on device safety and efficacy.
Following are the InMode Multi System specifications:
| Diode laser wavelength: | 810±20 nm |
|--------------------------------|-------------------------------------------------------|
| | 755nm/810nm±20 nm |
| | 810nm/1064nm±20 nm |
| Fluence | 5-40 J/cm² |
| Vasculaze laser wavelength: | 1064±20 nm |
| Fluence | 100-300 J/cm² |
| IPL wavelength: | 515 - 1200nm (SR 515) |
| | 580 - 1200nm (SR 580) |
| Fluence | 5-30 J/cm² |
| RF Max Output Power: | 65 Watt |
| RF Output Frequency: | 1[MHz] ± 2% |
| Dimension: | 46cm W x 46cm D x 100cm H [18.2" W x 18.2" D x 40" H] |
| Weight: | 32.0Kg [70.5lb] |
| Main Line Frequency (nominal): | 50-60 Hz |
| Input Voltage (nominal): | 100-240 VAC |
| Input Current (rms): | 12A |
### Intended Use/Indication for Use:
The InMode Multi System with the Diode laser Applicators is indicated for:
- . Diolaze XL 810nm Applicator 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.
- Diolaze XL 755/810nm & 810/1064nm Applicators are intended for hair ● removal.
- . VLaze Applicator is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.
The InMode Multi System with the IPL Applicator is indicated for:
- IPL Applicator with wavelengths (515-1200mm) is indicated for use for the following treatments: The treatment of benign pigmented epidermal lesions, including dyschromia. hyperpigmentation, melasma, ephelides (freckles); The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas
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and spider angiomas, poikilodenna of Civatte, superficial leg veins and venlous malformations.
The InMode Multi System with the non-invasive RF Applicators is indicated for:
- . BodyFX (WMBody) and MiniFX Applicators are intended for the treatment of the following medical conditions :Relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation; and temporary reduction in the appearance of cellulite.
- PLUS/ PLUS90/PLUS-PLUS (FORMA) and i-Forma Applicators are indicated ● for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
- . FaceFX (WMFace) Applicator is intended for use in dermatologic procedures, for noninvasive treatment of mild to moderate facial wrinkles and rhytids.
The InMode Multi System with the Fractional RF Applicators is indicated for:
- . FRACTORA 60 pin Applicator is intended for use in dermatological procedures requiring ablation and resurfacing of the skin.
- FRF 24 pin Applicator is intended for use in dermatologic and general surgical ● procedures for electrocoagulation and hemostasis.
- Fractora3D and Morpheus8 Applicators are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62 mJ/pin, use is limited to Skin Types I-V.
## Performance Standards:
The InMode Multi-System complies with the following recognized consensus standards:
- [Rec. Number 19-4] ANSI AAMI 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
[Rec. Number 5-89] IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- [Rec. Number 19-8] IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
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- [Rec. Number 6-389] IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
[Rec. Number 12-273] 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)]
- [Rec. Number 12-268] 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
- [Rec. Number 12-242] IEC 60601-2-57 Edition 1.0 2011-01Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
All the requirements of these standards were met. No adaptations were made to any of the test methods recommended in the standard. There were no applied deviations from the standard.
#### Non-Clinical (Bench) Performance Data:
Not Applicable
### Animal Performance Data / Histology Data:
Not Applicable
### Clinical Performance Data:
Not Applicable
### Biocompatibility
All of the modified device materials which come in direct contact with the patient skin are biocompatible and identical to the materials used in the manufacturing of the predicate devices.
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The following tables provide a comparison information for the InMode Multi-system and its primary predicate device; the InMode System and for the subject device applicators and their compatible secondary predicate devices:
## System platform:
| | InMode System<br>Primary Predicate Device; InMode<br>Ltd. K180719 | InMode Multi-system<br>Modified device;<br>InMode Ltd. |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification and Clinical Characteristics | | |
| Product Code | GEX | idem |
| Class | Class II | idem |
| Manufacturer | InMode Ltd. | idem |
| Prescription or<br>OTC | Prescription use only. | idem |
| Target Population | Adults requiring treatment as<br>specified in the indications for use. | idem |
| Anatomical sites | Body parts requiring treatment as<br>specified in the indications for use. | idem |
| Environment Used | Hospital or Clinic setting. | idem |
| Device Technological Characteristics | | |
| Device description<br>/ Design | The InMode System is a line<br>powered, computerized, software<br>controlled, platform system. The<br>system supports adjustable<br>handpieces for several clinical<br>indications. | idem |
| Device<br>components | The InMode System consists of the<br>following components: | The InMode Multi System<br>consists of the following<br>components: |
| | • Power supply unit,<br>• Controller<br>• LCD touch screen<br>• Diode laser driver<br>• Water cooling system<br>• Designated diode laser<br>applicators<br>• Single applicator connector<br>(for optical applicator)<br>• Footswitch<br>The InMode System platform was<br>also utilized under different<br>configurations, to support Laser,<br>RF and IPL technology-based<br>applicators as described in<br>K173677, K123860, K160329,<br>K131362, K172302, K102461,<br>K180189, K151273 & K200947.<br>The InMode System platform<br>supporting RF applicators consist<br>of the following components:<br>• Power supply unit,<br>• Controller<br>• LCD touch screen<br>• RF generator<br>• Designated RF applicators<br>• Two applicator connectors<br>• Footswitch | • Power supply unit,<br>• Controller<br>• LCD touch screen<br>• Diode laser driver<br>• IPL driver<br>• RF generator<br>• RF measuring circuit<br>• Water cooling system<br>• Designated diode laser,<br>IPL, and RF applicators<br>• Three applicator<br>connectors (one frontside<br>connector for optical<br>applicator and two rear<br>side connectors for RF<br>applicators)<br>• Footswitch |
| | The InMode System platform<br>supporting IPL applicators<br>consist of the following<br>components:<br>• Power supply unit,<br>• Controller<br>• LCD touch screen<br>• IPL driver<br>• Water cooling system<br>• Designated IPL applicators<br>• Single applicator connector | |
| | InMode System<br>Primary Predicate Device; InMode<br>Ltd. K180719 | InMode Multi-system<br>Modified device;<br>InMode Ltd. |
| Performance<br>specifications | Input power: 100-240V, 50-60 Hz,<br>12A | idem |
| Physical<br>specifications | Dimensions: 46cm W x 46cm D x<br>100cm H<br>[18.2" W x 18.2" D x 40" H]<br>Weight: 30 Kg (70.4 lbs.) | idem |
| Operating<br>parameters | Ambient Temperature Range: 15 -<br>30°C [59 - 86°F]<br>Relative Humidity: 30% to 80%,<br>non-condensing<br>Atmospheric Pressure: 90 - 110kPa | idem |
| Transport &<br>storage | Ambient Temperature Range: -20 -<br>65°C [-4 - 14°F]<br>Relative Humidity: 0% to 80%, non-<br>condensing<br>Atmospheric Pressure: 50 - 110kPa | idem |
| Compatibility<br>with Environment<br>and Other Devices | InMode System is compliant with<br>the IEC 60601-1-2 (EMC Safety)<br>standard | idem |
| Electrical Safety | Power Requirements:<br>100-240 VAC 50-60 Hz<br>The InMode System is compliant<br>with the IEC 60601-1 standard. | idem |
| Mechanical Safety | The InMode System is compliant<br>with the IEC 60601-1 standard. | idem |
| Chemical Safety | N/A | N/A |
| Thermal Safety | The InMode System is compliant<br>with the IEC 60601-1 standard. | idem |
| Radiation Safety | The InMode System is compliant<br>with the IEC 60601-1-2 (EMC<br>Safety) standard | idem |
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## Laser and IPL devices:
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| | InMode System<br>Secondary Predicate Devices;<br>InMode Ltd.<br>K180719- DIOLAZE XL<br>K173677 – Vlaze (Vasculaze)<br>K123860 – SR IPL (Lumecca)<br>1200nm) are indicated for use for<br>the following treatments:<br>• The treatment of benign<br>pigmented epidermal lesions,<br>including dyschromia,<br>hyperpigmentation, melasma,<br>ephelides (freckles);<br>• The treatment of benign<br>cutaneous vascular lesions,<br>including port wine stains,<br>facial, truncal and leg<br>telangiectasias, rosacea,<br>erythema of rosacea, angiomas<br>and spider angiomas,<br>poikilodenna of Civatte,<br>superficial leg veins and venlous<br>malformations. | InMode Multi-system<br>Modified device; InMode Ltd. |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Applicator Technological Characteristics | | |
| Weight | DIOLAZE XL: 0.45 Kg [0.99 lb]<br>VLaze (Vasculaze): 0.42 Kg [0.92 lb]<br>SR IPL (Lumecca): 0.575 Kg [1.27 lb] | idem |
| Applicator cable<br>length | 170 cm L [110`` L] | idem |
| Wavelength | DIOLAZE XL:<br>810±20 nm<br>755/810±20 nm<br>810/1064±20 nm<br>VLaze (Vasculaze):<br>1064±20 nm<br>SR IPL (Lumecca):<br>515 – 1200nm (SR 515)<br>580 – 1200nm (SR 580) | idem |
| Fluence | DIOLAZE XL: 5 – 40 J/cm2<br>VLaze (Vasculaze): 100 – 300 J/cm2<br>SR IPL (Lumecca): 5 – 30 J/cm2 | idem |
| Pulse width | DIOLAZE XL- 5-200 msec (pulse type : Short/Long) | idem |
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| | InMode System<br>Secondary Predicate Devices;<br>InMode Ltd.<br>K180719 - DIOLAZE XL<br>K173677 - Vlaze (Vasculaze)<br>K123860 - SR IPL (Lumecca) | InMode Multi-system<br>Modified device; InMode Ltd. |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| | VLaze: 5-200 msec | |
| Light guide<br>cooling | DIOLAZE XL: Strong: 7℃,<br>Normal: 12°C<br>VLaze (Vasculaze): Strong: 7ºC,<br>Normal: 12ºC<br>SR IPL (Lumecca): Strong - 15℃,<br>Normal - 22°C | idem |
| Spot size | DIOLAZE XL: 11mm X 27.5mm<br>VLaze (Vasculaze): 3mm X 4mm<br>SR IPL (Lumecca): 10mm X<br>30mm | idem |
Fractional RF Applicators:
| | InMode System<br>Secondary Predicate Devices;<br>InMode Ltd.<br>K102461 – FRACTORA 60 pin<br>K151273 – InMode FRF 24 pin<br>K180189 - Fractora3D<br>K200947 - Morpheus8 (12, 24, 40<br>& T tip heads) | InMode Multi-system<br>Modified device; InMode Ltd. |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| | Device Classification and Clinical Characteristics | |
| Product Code | GEI | idem |
| Class | Class II | idem |
| Manufacturer | InMode Ltd. | idem |
| Prescription or<br>OTC | Prescription use only | idem |
| Target Population | Adults requiring treatment as<br>specified in the indications for use. | idem |
| Anatomical sites | Body parts requiring treatment as<br>specified in the indications for use. | idem |
| Environment Used | Hospital or Clinic setting. | idem |
| Indications for use | FRACTORA 60: The InMode RF<br>Multi-System with the<br>FRACTORA 60 pin Applicator is | idem |
| | InMode System<br>Secondary Predicate Devices;<br>InMode Ltd. | InMode Multi-system<br>Modified device; InMode Ltd. |
| | K102461 – FRACTORA 60 pin<br>K151273 - InMode FRF 24 pin<br>K180189 - Fractora3D<br>K200947 - Morpheus8 (12, 24, 40 & T tip heads) | |
| | intended for use in dermatological<br>procedures requiring ablation and<br>resurfacing of the skin.<br>InMode FRF 24: The InMode RF<br>Multi-System with the 24 pin<br>Applicator is intended for use in<br>dermatologic and general surgical<br>procedures for electrocoagulation<br>and hemostasis.<br>At higher energy levels greater than<br>62 mJ/pin, use of the FRF<br>applicator is limited to Skin Types<br>I-IV.<br>FRACTORA 3D: The InMode<br>System with the Fractora3D<br>Applicators is intended for use in<br>dermatologic and general surgical<br>procedures for electrocoagulation<br>and hemostasis.<br>At higher energy levels greater than<br>62 mJ/pin, use of the Fractora3D<br>applicator is limited to Skin Types<br>I-IV.<br>Morpheus8: The InMode System<br>with the Morpheus8 Applicators is<br>intended for use in dermatological<br>procedures for electrocoagulation<br>and hemostasis.<br>At higher energy levels greater than<br>62 mJ/pin, use of the Morpheus8<br>(Fractora) applicator is limited to<br>Skin Types I-IV. | |
| Applicator Technological Characteristics | | |
| Weight | FRACTORA 60: 0.1 Kg [0.22 lb.]<br>InMode FRF 24: 0.1 Kg [0.22 lb.]<br>FRACTORA 3D: 0.4 Kg [0.88 lb.]<br>Morpheus8: 0.4 Kg [0.88 lb.] | idem |
| Pin length | FRACTORA 60: 200 microns<br>InMode FRF 24: 2.5 mm<br>FRACTORA 3D: 1-4 mm | idem |
| | InMode System<br>Secondary Predicate Devices;<br>InMode Ltd.<br>K102461 – FRACTORA 60 pin<br>K151273 – InMode FRF 24 pin<br>K180189- Fractora3D<br>K200947 – Morpheus8 (12, 24, 40<br>& T tip heads) | InMode Multi-system<br>Modified device; InMode Ltd. |
| | Morpheus8:<br>24, 40 pins: 7 mm (adjustable)<br>12 pins: 4 mm (adjustable)<br>T tip: 0.5 mm (fixed)…
