2.13 Equipment Classification
The following is a list of the different equipment used and their classifications.
▪ Electric shock protection: Class I, Defibrillation-proof Type B for the optical
Handpieces - DiolazeXL, Vasculaze and Lumecca, and Type BF for the RF
Handpieces – Fractora and Forma.
▪ Protection against ingress of liquids: Ordinary equipment.
▪ Not suitable for use in presence of flammable substance.
▪ Power receptacle must include protective earth and must be checked before
connecting the System.
The Optimas System with d DiolazeXL and Vasculaze 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 III
of the Medical Device Directive MDD 93/42/EEC. The Optimas System with DiolazeXL
and Vasculaze Handpieces is classified as a Class IV laser by the CDRH and as a Class 4
laser by the European Standard EN 60825-l.
The Optimas System with Lumecca IPL Handpieces is classified as IIb device
defined by the Medical Device Directive (93/42/EEC) for CE marking. The
Optimas System with RF Handpieces - Fractora and Forma is classified as IIb
device defined by the Medical Device Directive (93/42/EEC) for CE marking.
Use of controls or adjustments or performance of procedures other than
those specified herein may result in hazardous laser radiation exposure.
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