InMode Without Vasculaze Operator Manual
The InMode System with the Diolaze and DiolazeXL Handpieces complies with 21
CFR, Chapter L Subchapter J, as administered by the Center for Devices and
Radiological Health (CDRH) of the Food and Drug Administration (FDA). CE-labeled
devices comply with all appropriate performance standards as specified in Annex II of
the Medical Device Directive MDD 93/42/EEC. The InMode System with Diolaze and
DiolazeXL Handpieces is classified as a Class IV laser by the CDRH and as a Class 4
laser by the European Standard EN 60825-l.
Caution - Use of controls or adjustments or performance of procedures other than
those specified herein may result in hazardous laser radiation exposure.
The InMode System with IPL Handpiece is classified as IIb device defined by the
Medical Device Directive (93/42/EEC) for CE marking.
The InMode System with Fractora, Forma, Plus, and BodyFX/MiniFX Handpieces is
classified as IIb device defined by the Medical Device Directive (93/42/EEC) for CE
marking.
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