FDA.reportPublic FDA data

InMode , Ltd.

PMN#

GUDID#

InMode - InMode System 2 - color 2 - TritonThe InMode Diolaze XL System with the Diolaze XL 810nm Hand piece is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction inhair counts at 6, 9, or 12 months following a treatment regime.The InMode Diolaze XL System with the Diolaze XL 755/810nm & 810/1064nm Hand pieces is intended for hair removal. The InMode VLaze is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains,leg veins and other benign vascular lesions.

INMODE M.D LTD

2022-10-26

BodyTite Pro - The lnMode RF System generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation/contraction of soft tissue and hemostasis. The InMode RF System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating.The lnMode RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF handpiece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The handpiece is comprised of a disposable, single use plastic handle with internal and external electrodes.

INMODE M.D LTD

2024-05-19

Envision System - The Envision Platform with Forma-I, Forma, Morpheus8 and Lumecca Applicators employs two different technologies for various aesthetic applications – Intense Pulsed Light (IPL), and Radiofrequency (RF). The System operates while in contact with any of the following Handpieces: Forma-I and Forma Handpieces employs bi-polar Radiofrequency (RF) technology for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation; Lumecca IPL for treatment of superficial vascular and pigmented lesions; and Morpheus8 for electro-coagulation. The device provides individual adjustment of treatment parameters to achieve maximum efficiency and safety for each patient and applications.

INMODE M.D LTD

2024-03-24

EmPowerRF platform - InMode RF Pro system with the non-invasive applicators employs RF energy for various applications:• i-Forma, Forma (Plus), Plus (Plus Plus) and Plus90 for relief of minor muscle aches and pain, relief of muscle spasm,and temporary improvement of local blood circulation.• WMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinklesand rhytids.• BodyFX™ (WMBody)/MiniFX™ for Relief of minor muscle aches and pain, relief of muscle spasm, temporaryimprovement of local blood circulation and temporary reduction in the appearance of cellulite.The InMode RF Pro System with the Fractional Applicators employs RF energy for various applications:• Fractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacingof the skin.• Fractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures forelectrocoagulation and hemostasis.At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV• Morpheus8™ for dermatological and general surgical procedures for electrocoagulation and hemostasis.At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV

INMODE M.D LTD

2022-10-25

80 records. Showing 1-40. Next