(30 days)
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 mJ/pin, use is limited to Skin Types I-V.
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 -
- Fractora o
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".
This document describes an FDA 510(k) premarket notification for the InMode Multi-system, a medical device with various applicators for dermatological and general surgical procedures. The submission claims substantial equivalence to previously cleared predicate devices.
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity, specificity, or metrics for effectiveness. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices. This means that the device is shown to be as safe and effective as a legally marketed device that does not require premarket approval.
The reported device performance is broadly stated as maintaining the same safety and effectiveness as the predicate devices:
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Safety (Electrical, Mechanical, Thermal, Radiation) | Complies with recognized consensus standards (e.g., ANSI AAMI ES 60601-1, IEC 60601-1-6, IEC 60601-1-2, IEC 60601-2-2, IEC 60825-1, IEC 60601-2-22, IEC 60601-2-57). "The safety features and compliance with safety standards of the InMode Multi system are identical to the safety features and compliance with safety standards of the predicate devices." |
| Effectiveness (Clinical Indications) | "The indications for use and technological characteristics of the InMode Multi system (subject device) are substantially equivalent to the indications for use and technological characteristics of the InMode system (primary predicate device) and of the applicators predicate devices (secondary predicate devices)." |
| 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." |
| Performance Specifications | "Both the subject and predicate devices present identical performance specifications (for the specified indications for use) and identical monitoring features (where applicable) in order to maintain the desired performance specifications." (See detailed specifications in tables in prompt) |
| Technological Characteristics | "The subject device applicators possess identical technological principals to that of the predicate devices' applicators." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states:
- Non-Clinical (Bench) Performance Data: Not Applicable
- Animal Performance Data / Histology Data: Not Applicable
- Clinical Performance Data: Not Applicable
Therefore, there is no mention of a test set, sample size, or data provenance from clinical studies for this 510(k) submission. The device's substantial equivalence is based on engineering comparisons and compliance with recognized standards.
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 applicable, as no clinical performance data or test set was used for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical performance data or test set was used.
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 applicable. This device is not an AI-assisted diagnostic or interpretation tool; it is a physical device (laser, IPL, RF system) for treatments. No MRMC study was mentioned or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical performance data was used for this submission. The "ground truth" for demonstrating substantial equivalence relies on the established safety and effectiveness of the predicate devices and the technical comparison performed.
8. The sample size for the training set
Not applicable, as no AI/machine learning model is being described or used in a way that requires a training set for this 510(k) submission.
9. How the ground truth for the training set was established
Not applicable, as no AI/machine learning model is being described.
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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.,Kfar Saba 4442518, IsraelTel: +972-9-7670002Fax: +972-9-7668534E-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
{4}------------------------------------------------
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 DeviceComponent | RegulationNumber | ProductCode | Primary/Secondarypredicate device | Predicatedevice 510(K)number |
|---|---|---|---|---|
| Main platform/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 RFApplicators:FRACTORA 60Pin, InMode FRF24 Pin,Morpheus8,FRACTORA 3DApplicators | 878.4810 | GEI | Secondary | K200947,K180189,K151273,K102461 |
| BodyFX(WMBody)Applicator | 878.4810890.5560 | NUV,ISA | Secondary | K131362 |
| MiniFXApplicator | 878.4400890.5560 | GEI,ISA | Secondary | K160329 |
| Forma (Plus),Plus90 and Plus(Plus-Plus)Applicators | 878.4400890.5560 | PBX,ISA | Secondary | K172302 |
| i-FormaApplicator | 878.4400890.5560 | PBX,ISA | Secondary | K210492 |
| WMFaceApplicator | 878.4400 | GEI, | Secondary | K140926 |
{5}------------------------------------------------
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 -
- Fractora o
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".
{6}------------------------------------------------
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
{7}------------------------------------------------
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
{8}------------------------------------------------
-
[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.
{9}------------------------------------------------
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 SystemPrimary Predicate Device; InModeLtd. K180719 | InMode Multi-systemModified device;InMode Ltd. | |
|---|---|---|
| Device Classification and Clinical Characteristics | ||
| Product Code | GEX | idem |
| Class | Class II | idem |
| Manufacturer | InMode Ltd. | idem |
| Prescription orOTC | Prescription use only. | idem |
| Target Population | Adults requiring treatment asspecified in the indications for use. | idem |
| Anatomical sites | Body parts requiring treatment asspecified in the indications for use. | idem |
| Environment Used | Hospital or Clinic setting. | idem |
| Device Technological Characteristics | ||
| Device description/ Design | The InMode System is a linepowered, computerized, softwarecontrolled, platform system. Thesystem supports adjustablehandpieces for several clinicalindications. | idem |
| Devicecomponents | The InMode System consists of thefollowing components: | The InMode Multi Systemconsists of the followingcomponents: |
| • Power supply unit,• Controller• LCD touch screen• Diode laser driver• Water cooling system• Designated diode laserapplicators• Single applicator connector(for optical applicator)• FootswitchThe InMode System platform wasalso utilized under differentconfigurations, to support Laser,RF and IPL technology-basedapplicators as described inK173677, K123860, K160329,K131362, K172302, K102461,K180189, K151273 & K200947.The InMode System platformsupporting RF applicators consistof the following components:• Power supply unit,• Controller• LCD touch screen• RF generator• Designated RF applicators• Two applicator connectors• Footswitch | • Power supply unit,• Controller• LCD touch screen• Diode laser driver• IPL driver• RF generator• RF measuring circuit• Water cooling system• Designated diode laser,IPL, and RF applicators• Three applicatorconnectors (one frontsideconnector for opticalapplicator and two rearside connectors for RFapplicators)• Footswitch | |
| The InMode System platformsupporting IPL applicatorsconsist of the followingcomponents:• Power supply unit,• Controller• LCD touch screen• IPL driver• Water cooling system• Designated IPL applicators• Single applicator connector | ||
| InMode SystemPrimary Predicate Device; InModeLtd. K180719 | InMode Multi-systemModified device;InMode Ltd. | |
| Performancespecifications | Input power: 100-240V, 50-60 Hz,12A | idem |
| Physicalspecifications | Dimensions: 46cm W x 46cm D x100cm H[18.2" W x 18.2" D x 40" H]Weight: 30 Kg (70.4 lbs.) | idem |
| Operatingparameters | Ambient Temperature Range: 15 -30°C [59 - 86°F]Relative Humidity: 30% to 80%,non-condensingAtmospheric Pressure: 90 - 110kPa | idem |
| Transport &storage | Ambient Temperature Range: -20 -65°C [-4 - 14°F]Relative Humidity: 0% to 80%, non-condensingAtmospheric Pressure: 50 - 110kPa | idem |
| Compatibilitywith Environmentand Other Devices | InMode System is compliant withthe IEC 60601-1-2 (EMC Safety)standard | idem |
| Electrical Safety | Power Requirements:100-240 VAC 50-60 HzThe InMode System is compliantwith the IEC 60601-1 standard. | idem |
| Mechanical Safety | The InMode System is compliantwith the IEC 60601-1 standard. | idem |
| Chemical Safety | N/A | N/A |
| Thermal Safety | The InMode System is compliantwith the IEC 60601-1 standard. | idem |
| Radiation Safety | The InMode System is compliantwith the IEC 60601-1-2 (EMCSafety) standard | idem |
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Laser and IPL devices:
{13}------------------------------------------------
| InMode SystemSecondary Predicate Devices;InMode Ltd.K180719- DIOLAZE XLK173677 – Vlaze (Vasculaze)K123860 – SR IPL (Lumecca)1200nm) are indicated for use forthe following treatments:• The treatment of benignpigmented epidermal lesions,including dyschromia,hyperpigmentation, melasma,ephelides (freckles);• The treatment of benigncutaneous vascular lesions,including port wine stains,facial, truncal and legtelangiectasias, rosacea,erythema of rosacea, angiomasand spider angiomas,poikilodenna of Civatte,superficial leg veins and venlousmalformations. | InMode Multi-systemModified device; InMode Ltd. | |
|---|---|---|
| Applicator Technological Characteristics | ||
| Weight | DIOLAZE XL: 0.45 Kg [0.99 lb]VLaze (Vasculaze): 0.42 Kg [0.92 lb]SR IPL (Lumecca): 0.575 Kg [1.27 lb] | idem |
| Applicator cablelength | 170 cm L [110`` L] | idem |
| Wavelength | DIOLAZE XL:810±20 nm755/810±20 nm810/1064±20 nmVLaze (Vasculaze):1064±20 nmSR IPL (Lumecca):515 – 1200nm (SR 515)580 – 1200nm (SR 580) | idem |
| Fluence | DIOLAZE XL: 5 – 40 J/cm2VLaze (Vasculaze): 100 – 300 J/cm2SR IPL (Lumecca): 5 – 30 J/cm2 | idem |
| Pulse width | DIOLAZE XL- 5-200 msec (pulse type : Short/Long) | idem |
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| InMode SystemSecondary Predicate Devices;InMode Ltd.K180719 - DIOLAZE XLK173677 - Vlaze (Vasculaze)K123860 - SR IPL (Lumecca) | InMode Multi-systemModified device; InMode Ltd. | |
|---|---|---|
| VLaze: 5-200 msec | ||
| Light guidecooling | DIOLAZE XL: Strong: 7℃,Normal: 12°CVLaze (Vasculaze): Strong: 7ºC,Normal: 12ºCSR IPL (Lumecca): Strong - 15℃,Normal - 22°C | idem |
| Spot size | DIOLAZE XL: 11mm X 27.5mmVLaze (Vasculaze): 3mm X 4mmSR IPL (Lumecca): 10mm X30mm | idem |
Fractional RF Applicators:
| InMode SystemSecondary Predicate Devices;InMode Ltd.K102461 – FRACTORA 60 pinK151273 – InMode FRF 24 pinK180189 - Fractora3DK200947 - Morpheus8 (12, 24, 40& T tip heads) | InMode Multi-systemModified device; InMode Ltd. | |
|---|---|---|
| Device Classification and Clinical Characteristics | ||
| Product Code | GEI | idem |
| Class | Class II | idem |
| Manufacturer | InMode Ltd. | idem |
| Prescription orOTC | Prescription use only | idem |
| Target Population | Adults requiring treatment asspecified in the indications for use. | idem |
| Anatomical sites | Body parts requiring treatment asspecified in the indications for use. | idem |
| Environment Used | Hospital or Clinic setting. | idem |
| Indications for use | FRACTORA 60: The InMode RFMulti-System with theFRACTORA 60 pin Applicator is | idem |
| InMode SystemSecondary Predicate Devices;InMode Ltd. | InMode Multi-systemModified device; InMode Ltd. | |
| K102461 – FRACTORA 60 pinK151273 - InMode FRF 24 pinK180189 - Fractora3DK200947 - Morpheus8 (12, 24, 40 & T tip heads) | ||
| intended for use in dermatologicalprocedures requiring ablation andresurfacing of the skin.InMode FRF 24: The InMode RFMulti-System with the 24 pinApplicator is intended for use indermatologic and general surgicalprocedures for electrocoagulationand hemostasis.At higher energy levels greater than62 mJ/pin, use of the FRFapplicator is limited to Skin TypesI-IV.FRACTORA 3D: The InModeSystem with the Fractora3DApplicators is intended for use indermatologic and general surgicalprocedures for electrocoagulationand hemostasis.At higher energy levels greater than62 mJ/pin, use of the Fractora3Dapplicator is limited to Skin TypesI-IV.Morpheus8: The InMode Systemwith the Morpheus8 Applicators isintended for use in dermatologicalprocedures for electrocoagulationand hemostasis.At higher energy levels greater than62 mJ/pin, use of the Morpheus8(Fractora) applicator is limited toSkin Types I-IV. | ||
| Applicator Technological Characteristics | ||
| Weight | FRACTORA 60: 0.1 Kg [0.22 lb.]InMode FRF 24: 0.1 Kg [0.22 lb.]FRACTORA 3D: 0.4 Kg [0.88 lb.]Morpheus8: 0.4 Kg [0.88 lb.] | idem |
| Pin length | FRACTORA 60: 200 micronsInMode FRF 24: 2.5 mmFRACTORA 3D: 1-4 mm | idem |
| InMode SystemSecondary Predicate Devices;InMode Ltd.K102461 – FRACTORA 60 pinK151273 – InMode FRF 24 pinK180189- Fractora3DK200947 – Morpheus8 (12, 24, 40& T tip heads) | InMode Multi-systemModified device; InMode Ltd. | |
| Morpheus8:24, 40 pins: 7 mm (adjustable)12 pins: 4 mm (adjustable)T tip: 0.5 mm (fixed) | ||
| Maximum outputpower | FRACTORA 60: 65WInMode FRF 24: 65WFRACTORA 3D: 65WMorpheus8: 65W | idem |
| RF frequency | FRACTORA 60: 1 MHzInMode FRF 24: 1 MHzFRACTORA 3D: 1 MHzMorpheus8: 1 MHz | idem |
| Sterilization and reprocessing | ||
| Sterilization | All tip heads are Gamma sterilized | idem |
| Reprocessing | All applicator handles are formultiple useAll tip heads are for single use | idem |
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Non-invasive RF Applicators:
| InMode SystemSecondary Predicate Devices;InMode Ltd.K131362 – BodyFX (WMBody)K160329 – MiniFXK172302 –PLUS/PLUS90/PLUS-PLUS | InMode Multi-systemModified device; InModeLtd. | |
|---|---|---|
| Device Classification and Clinical Characteristics | ||
| Product Code | PBX, ISA, NUV, GEI | idem |
| Class | Class II | idem |
| Manufacturer | InMode Ltd. | idem |
| Prescription orOTC | Prescription use only | idem |
| InMode SystemSecondary Predicate Devices;InMode Ltd. | InMode Multi-systemModified device; InModeLtd. | |
| K131362 - BodyFX (WMBody)K160329 - MiniFXK172302 -PLUS/PLUS90/PLUS-PLUS | ||
| Target Population | Adults requiring treatment asspecified in the indications for use. | idem |
| Anatomical sites | Body parts requiring treatment asspecified in the indications for use. | idem |
| Environment Used | Hospital or Clinic setting. | idem |
| Indications for use | BodyFX: The WMBody Applicatoris intended for the treatment of thefollowing medical conditions usingnon-thermal RF combined withmassage:Relief of minor muscle aches andpains, relief of muscle spasm,temporary improvement of localblood circulation.Temporary reduction in theappearance of celluliteMiniFX: The MiniFX Applicator isintended for the treatment of thefollowing medical conditions usingnon-thermal RF combined withmassage:Relief of minor muscle aches andpains, relief of muscle spasm,temporary improvement of localblood circulation.Temporary reduction in theappearance of cellulitePLUS/PLUS90/PLUS-PLUS/i-Forma: The PLUS/PLUS90/PLUS-PLUS/i-Forma Applicators areindicated for the temporary relief ofminor muscle aches and pain,temporary relief of muscle spasm,and temporary improvement of localblood circulation.WMFace: The WMFace Applicatoris intended for use in dermatologicprocedures, for noninvasive | idem |
| InMode SystemSecondary Predicate Devices;InMode Ltd.K131362 - BodyFX (WMBody)K160329 - MiniFXK172302 -PLUS/PLUS90/PLUS-PLUStreatment of mild to moderate facialwrinkles and rhytids. | InMode Multi-systemModified device; InModeLtd. | |
| Applicator Technological Characteristics | ||
| Weight | BodyFX: 1 Kg [2.2 lb.]MiniFX: 0.75 Kg [1.6 lb.]PLUS/PLUS90: 0.11 Kg [0.24 lb.]PLUS-PLUS: 0.17 Kg [0.35 lb.]i-Forma: 0.35kg [0.77 Ib]WMFace: 1 Kg [2.2 lbs.] | idem |
| Maximum outputpower | BodyFX: 50WMiniFX: 25WPLUS/PLUS90/PLUS-PLUS: 50Wi-Forma: 12WWMFace: 65W | idem |
| RF frequency | BodyFX: 1 MHzMiniFX: 1 MHzPLUS/PLUS90/PLUS-PLUS:1 MHzi-Forma: 1 MHzWMFace: 1 MHz | idem |
| Vacuum | BodyFX: Automatically controlled,MiniFX: Automatically controlled,PLUS/PLUS90/PLUS-PLUS/i-Forma/WMFace: N/A | idem |
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Comparison Discussion:
To summarize, the indications for use and technological characteristics of the InMode Multi system (subject device) are substantially equivalent to the indications for use and technological characteristics of the InMode system (primary predicate device) and of the applicators predicate devices (secondary predicate devices).
The design of and components included in the InMode Multi system, including the main system platform are identical to the design and components found in the primary predicate device except for slight design modifications to support the utilization of all of the system
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applicators, mainly in software design. The subject device applicators possess identical technological principals to that of the predicate devices' applicators. The subject device performance and safety are maintained due to the exact functionality and mechanism of operation to that of the predicate devices.
Both the subject and predicate devices present identical performance specifications (for the specified indications for use) and identical monitoring features (where applicable) in order to maintain the desired performance specifications. The safety features and compliance with safety standards of the InMode Multi system are identical to the safety features and compliance with safety standards of the predicate devices. Patient contacting materials are also identical. Any minor differences in the technological characteristics do not raise new safety or effectiveness concerns. Furthermore, the subject device underwent performance testing including software validation testing, electrical and mechanical safety testing, electromagnetic compatibility testing and specific testing for RF and laser technologies. User interface was slightly changed in order to support all applicators, and labeling was updated to allow appropriate use.
Consequently, it can be concluded that the InMode Multi system is substantially equivalent to the primary predicate; the InMode system (FDA-Cleared under 510(k) K180719) and to its complement secondary predicate devices (per system Applicator), and therefore may be legally marketed in the USA.
§ 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.