InMode Multi-system

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 (515-1200nm) 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, poikiloderma of Civatte, superficial leg veins and venous 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-IV.

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 (515-1200nm) 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, poikiloderma of Civatte, superficial leg veins and venous 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.

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
  o Diolaze XL 755/810nm
  o Diolaze XL 810/1064nm
  o VLaze (Vasculaze)
• IPL Applicator:
  o SR IPL (Lumecca 580, Lumecca 515)
• Non-Invasive RF Applicators:
  o Forma (Plus)
  o Plus (Plus Plus)
  o Plus90
  o i-Forma
  o BodyFX™ (WMBody)
  o MiniFX™
  o WMFace
• Fractional RF Applicators:
  o Fractora
    - 24 pins tip (FRF)
    - 60 pins tip
  o Morpheus8™
    - 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 and operation 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''. The abovementioned modifications have no significant influence on device safety and efficacy.