(30 days)
Not Found
No
The document describes a multi-system platform with various applicators for different energy-based treatments (laser, IPL, RF). While software modifications are mentioned, there is no indication or mention of AI or ML technology being incorporated for image processing, data analysis, or treatment optimization. The focus is on the energy delivery and the specific indications for each applicator.
Yes
The device is intended for various medical conditions, including the relief of minor muscle aches and pains, muscle spasms, temporary improvement of local blood circulation, and treatment of vascular lesions. These are therapeutic uses.
No
The document describes treatments for various conditions such as hair removal, vascular lesions, pigmented lesions, muscle aches, and skin resurfacing. It does not mention any function for diagnosing medical conditions.
No
The device description explicitly states it comprises a system platform and compatible set of applicators, which are hardware components. It also mentions slight modifications to the platform hardware. While software modifications were made, the device is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The InMode Multi System with its various applicators is described as using radiofrequency, laser, or IPL energy to treat various conditions directly on the patient's body. The intended uses listed are for procedures like hair removal, treatment of vascular lesions, treatment of pigmented lesions, temporary relief of muscle aches and pains, temporary reduction in the appearance of cellulite, and treatment of wrinkles and rhytids.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient. The treatments are applied externally or minimally invasively to the body.
Therefore, the InMode Multi System falls under the category of therapeutic or aesthetic medical devices, not In Vitro Diagnostics.
N/A
Intended Use / 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, ephelides (freckles); 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 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX, GEI, ONF, NUV, ISA, PBX
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:
- Diolaze XL 810nm
- Diolaze XL 755/810nm
- Diolaze XL 810/1064nm
- VLaze (Vasculaze)
- IPL Applicator:
- SR IPL (Lumecca 580, Lumecca 515)
- Non-Invasive RF Applicators:
- Forma (Plus)
- Plus (Plus Plus)
- Plus90
- i-Forma
- BodyFX™ (WMBody)
- MiniFXTM
- WMFace
- Fractional RF Applicators:
- Fractora
- 24 pins tip (FRF)
- 60 pins tip
- Morpheus8TM
- 12 pins tip (Prime Tip)
- 24 pins tip (Fractora 3D)
- 40 pins tip (Body Tip)
- T tip
- Fractora
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".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body parts requiring treatment as specified in the indications for use.
Indicated Patient Age Range
Adults requiring treatment as specified in the indications for use.
Intended User / Care Setting
Hospital or Clinic setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K180719, K180719, K173677, K123860, K200947, K180189, K151273, K102461, K131362, K160329, K172302, K210492, K140926
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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.
3
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, Israel | |
| Tel: +972-9-7670002 | |
| Fax: +972-9-7668534 | |
| 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
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 Device
Component | Regulation
Number | Product
Code | Primary/Secondary
predicate device | Predicate
device 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 RF
Applicators:
FRACTORA 60
Pin, InMode FRF
24 Pin,
Morpheus8,
FRACTORA 3D
Applicators | 878.4810 | GEI | Secondary | K200947,
K180189,
K151273,
K102461 |
| BodyFX
(WMBody)
Applicator | 878.4810
890.5560 | NUV,
ISA | Secondary | K131362 |
| MiniFX
Applicator | 878.4400
890.5560 | GEI,
ISA | Secondary | K160329 |
| Forma (Plus),
Plus90 and Plus
(Plus-Plus)
Applicators | 878.4400
890.5560 | PBX,
ISA | Secondary | K172302 |
| i-Forma
Applicator | 878.4400
890.5560 | PBX,
ISA | Secondary | K210492 |
| WMFace
Applicator | 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 System
Primary Predicate Device; InMode
Ltd. K180719 | InMode Multi-system
Modified device;
InMode Ltd. |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification and Clinical Characteristics | | |
| Product Code | GEX | idem |
| Class | Class II | idem |
| Manufacturer | InMode Ltd. | idem |
| Prescription or
OTC | Prescription use only. | idem |
| Target Population | Adults requiring treatment as
specified in the indications for use. | idem |
| Anatomical sites | Body parts requiring treatment as
specified in the indications for use. | idem |
| Environment Used | Hospital or Clinic setting. | idem |
| Device Technological Characteristics | | |
| Device description
/ Design | The InMode System is a line
powered, computerized, software
controlled, platform system. The
system supports adjustable
handpieces for several clinical
indications. | idem |
| Device
components | The InMode System consists of the
following components: | The InMode Multi System
consists of the following
components: |
| | • Power supply unit,
• Controller
• LCD touch screen
• Diode laser driver
• Water cooling system
• Designated diode laser
applicators
• Single applicator connector
(for optical applicator)
• Footswitch
The InMode System platform was
also utilized under different
configurations, to support Laser,
RF and IPL technology-based
applicators as described in
K173677, K123860, K160329,
K131362, K172302, K102461,
K180189, K151273 & K200947.
The InMode System platform
supporting RF applicators consist
of 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 applicator
connectors (one frontside
connector for optical
applicator and two rear
side connectors for RF
applicators)
• Footswitch |
| | The InMode System platform
supporting IPL applicators
consist of the following
components:
• Power supply unit,
• Controller
• LCD touch screen
• IPL driver
• Water cooling system
• Designated IPL applicators
• Single applicator connector | |
| | InMode System
Primary Predicate Device; InMode
Ltd. K180719 | InMode Multi-system
Modified device;
InMode Ltd. |
| Performance
specifications | Input power: 100-240V, 50-60 Hz,
12A | idem |
| Physical
specifications | Dimensions: 46cm W x 46cm D x
100cm H
[18.2" W x 18.2" D x 40" H]
Weight: 30 Kg (70.4 lbs.) | idem |
| Operating
parameters | Ambient Temperature Range: 15 -
30°C [59 - 86°F]
Relative Humidity: 30% to 80%,
non-condensing
Atmospheric Pressure: 90 - 110kPa | idem |
| Transport &
storage | Ambient Temperature Range: -20 -
65°C [-4 - 14°F]
Relative Humidity: 0% to 80%, non-
condensing
Atmospheric Pressure: 50 - 110kPa | idem |
| Compatibility
with Environment
and Other Devices | InMode System is compliant with
the IEC 60601-1-2 (EMC Safety)
standard | idem |
| Electrical Safety | Power Requirements:
100-240 VAC 50-60 Hz
The InMode System is compliant
with the IEC 60601-1 standard. | idem |
| Mechanical Safety | The InMode System is compliant
with the IEC 60601-1 standard. | idem |
| Chemical Safety | N/A | N/A |
| Thermal Safety | The InMode System is compliant
with the IEC 60601-1 standard. | idem |
| Radiation Safety | The InMode System is compliant
with the IEC 60601-1-2 (EMC
Safety) standard | idem |
10
11
12
Laser and IPL devices:
13
| | InMode System
Secondary Predicate Devices;
InMode Ltd.
K180719- DIOLAZE XL
K173677 – Vlaze (Vasculaze)
K123860 – SR IPL (Lumecca)
1200nm) are 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
and spider angiomas,
poikilodenna of Civatte,
superficial leg veins and venlous
malformations. | InMode Multi-system
Modified 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 cable
length | 170 cm L [110`` L] | idem |
| Wavelength | DIOLAZE XL:
810±20 nm
755/810±20 nm
810/1064±20 nm
VLaze (Vasculaze):
1064±20 nm
SR IPL (Lumecca):
515 – 1200nm (SR 515)
580 – 1200nm (SR 580) | idem |
| Fluence | DIOLAZE XL: 5 – 40 J/cm2
VLaze (Vasculaze): 100 – 300 J/cm2
SR IPL (Lumecca): 5 – 30 J/cm2 | idem |
| Pulse width | DIOLAZE XL- 5-200 msec (pulse type : Short/Long) | idem |
14
| | InMode System
Secondary Predicate Devices;
InMode Ltd.
K180719 - DIOLAZE XL
K173677 - Vlaze (Vasculaze)
K123860 - SR IPL (Lumecca) | InMode Multi-system
Modified device; InMode Ltd. |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| | VLaze: 5-200 msec | |
| Light guide
cooling | DIOLAZE XL: Strong: 7℃,
Normal: 12°C
VLaze (Vasculaze): Strong: 7ºC,
Normal: 12ºC
SR IPL (Lumecca): Strong - 15℃,
Normal - 22°C | idem |
| Spot size | DIOLAZE XL: 11mm X 27.5mm
VLaze (Vasculaze): 3mm X 4mm
SR IPL (Lumecca): 10mm X
30mm | idem |
Fractional RF Applicators:
| | InMode System
Secondary Predicate Devices;
InMode Ltd.
K102461 – FRACTORA 60 pin
K151273 – InMode FRF 24 pin
K180189 - Fractora3D
K200947 - Morpheus8 (12, 24, 40
& T tip heads) | InMode Multi-system
Modified device; InMode Ltd. |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| | Device Classification and Clinical Characteristics | |
| Product Code | GEI | idem |
| Class | Class II | idem |
| Manufacturer | InMode Ltd. | idem |
| Prescription or
OTC | Prescription use only | idem |
| Target Population | Adults requiring treatment as
specified in the indications for use. | idem |
| Anatomical sites | Body parts requiring treatment as
specified in the indications for use. | idem |
| Environment Used | Hospital or Clinic setting. | idem |
| Indications for use | FRACTORA 60: The InMode RF
Multi-System with the
FRACTORA 60 pin Applicator is | idem |
| | InMode System
Secondary Predicate Devices;
InMode Ltd. | InMode Multi-system
Modified device; InMode Ltd. |
| | K102461 – FRACTORA 60 pin
K151273 - InMode FRF 24 pin
K180189 - Fractora3D
K200947 - Morpheus8 (12, 24, 40 & T tip heads) | |
| | intended for use in dermatological
procedures requiring ablation and
resurfacing of the skin.
InMode FRF 24: The InMode RF
Multi-System with the 24 pin
Applicator is intended for use in
dermatologic and general surgical
procedures for electrocoagulation
and hemostasis.
At higher energy levels greater than
62 mJ/pin, use of the FRF
applicator is limited to Skin Types
I-IV.
FRACTORA 3D: The InMode
System with the Fractora3D
Applicators is intended for use in
dermatologic and general surgical
procedures for electrocoagulation
and hemostasis.
At higher energy levels greater than
62 mJ/pin, use of the Fractora3D
applicator is limited to Skin Types
I-IV.
Morpheus8: The InMode System
with the Morpheus8 Applicators is
intended for use in dermatological
procedures for electrocoagulation
and hemostasis.
At higher energy levels greater than
62 mJ/pin, use of the Morpheus8
(Fractora) applicator is limited to
Skin 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 microns
InMode FRF 24: 2.5 mm
FRACTORA 3D: 1-4 mm | idem |
| | InMode System
Secondary Predicate Devices;
InMode Ltd.
K102461 – FRACTORA 60 pin
K151273 – InMode FRF 24 pin
K180189- Fractora3D
K200947 – Morpheus8 (12, 24, 40
& T tip heads) | InMode Multi-system
Modified device; InMode Ltd. |
| | Morpheus8:
24, 40 pins: 7 mm (adjustable)
12 pins: 4 mm (adjustable)
T tip: 0.5 mm (fixed) | |
| Maximum output
power | FRACTORA 60: 65W
InMode FRF 24: 65W
FRACTORA 3D: 65W
Morpheus8: 65W | idem |
| RF frequency | FRACTORA 60: 1 MHz
InMode FRF 24: 1 MHz
FRACTORA 3D: 1 MHz
Morpheus8: 1 MHz | idem |
| Sterilization and reprocessing | | |
| Sterilization | All tip heads are Gamma sterilized | idem |
| Reprocessing | All applicator handles are for
multiple use
All tip heads are for single use | idem |
15
16
Non-invasive RF Applicators:
| | InMode System
Secondary Predicate Devices;
InMode Ltd.
K131362 – BodyFX (WMBody)
K160329 – MiniFX
K172302 –
PLUS/PLUS90/PLUS-PLUS | InMode Multi-system
Modified device; InMode
Ltd. |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Device Classification and Clinical Characteristics | | |
| Product Code | PBX, ISA, NUV, GEI | idem |
| Class | Class II | idem |
| Manufacturer | InMode Ltd. | idem |
| Prescription or
OTC | Prescription use only | idem |
| | InMode System
Secondary Predicate Devices;
InMode Ltd. | InMode Multi-system
Modified device; InMode
Ltd. |
| | K131362 - BodyFX (WMBody)
K160329 - MiniFX
K172302 -
PLUS/PLUS90/PLUS-PLUS | |
| Target Population | Adults requiring treatment as
specified in the indications for use. | idem |
| Anatomical sites | Body parts requiring treatment as
specified in the indications for use. | idem |
| Environment Used | Hospital or Clinic setting. | idem |
| Indications for use | BodyFX: The WMBody Applicator
is intended for the treatment of the
following medical conditions using
non-thermal RF combined with
massage:
Relief of minor muscle aches and
pains, relief of muscle spasm,
temporary improvement of local
blood circulation.
Temporary reduction in the
appearance of cellulite
MiniFX: The MiniFX Applicator is
intended for the treatment of the
following medical conditions using
non-thermal RF combined with
massage:
Relief of minor muscle aches and
pains, relief of muscle spasm,
temporary improvement of local
blood circulation.
Temporary reduction in the
appearance of cellulite
PLUS/PLUS90/PLUS-PLUS/i-
Forma: The PLUS/PLUS90/PLUS-
PLUS/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.
WMFace: The WMFace Applicator
is intended for use in dermatologic
procedures, for noninvasive | idem |
| | InMode System
Secondary Predicate Devices;
InMode Ltd.
K131362 - BodyFX (WMBody)
K160329 - MiniFX
K172302 -
PLUS/PLUS90/PLUS-PLUS
treatment of mild to moderate facial
wrinkles and rhytids. | InMode Multi-system
Modified device; InMode
Ltd. |
| 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 output
power | BodyFX: 50W
MiniFX: 25W
PLUS/PLUS90/PLUS-PLUS: 50W
i-Forma: 12W
WMFace: 65W | idem |
| RF frequency | BodyFX: 1 MHz
MiniFX: 1 MHz
PLUS/PLUS90/PLUS-PLUS:
1 MHz
i-Forma: 1 MHz
WMFace: 1 MHz | idem |
| Vacuum | BodyFX: Automatically controlled,
MiniFX: Automatically controlled,
PLUS/PLUS90/PLUS-PLUS/i-
Forma/WMFace: N/A | idem |
17
18
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
19
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.