Fraxel
®
1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
Part Number 10-05170 Rev. O
Page 79 of 92
8.0 Safety Standards and Regulatory
Classifications
8.1 General
Standards
The Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser Systems are compliant to
and have been certified as meeting the following FDA, CDRH standards. Formal
compliance certifications to the IEC 60601-1 based standards will be obtained through TUV
Rheinland of N.A. and TUV Rheinland GmbH.
FDA – CDRH 21 CFR 1040
FDA – Laser Notice 50
Warning:
The Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser Systems are classified to
contain Class 4 lasers by the Center for Devices and Radiological Health and by IEC / EN.
This classification represents the highest power laser. The output power is in excess of 300
times the maximum permissible exposure per ANSI Z136 and IEC60825-1. The physician
and associated staff must take precautions to prevent exposure of laser energy to the eye
and unintended skin exposure from either direct or diffusely reflected laser beams. In
addition, precautions must be taken in the surgical environment to prevent hazards of fire
and electrical injury.
Warning:
In compliance with CAN/CSA-Z386-08, it is the responsibility of the user to be aware of the
requirements for safe use of the Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927
Laser Systems. This includes training in laser safety and responsibility for the physical
facility and its signs, proper use of protective eyewear and other safety measures, both for
protection of the patient, or others who may be potentially exposed to hazards associated
with use of the device. This also includes maintenance and other practices required for safe
operation of the device. If needed, the user should consult a safety expert, a consultant, or
other sources regarding safety related issues such as site assessment, hazard evaluation,
problem solving, or compliance enforcement.
European Community Authorized Representative
MDSS GmbH
Schiffgraben 41
D-30175 Hannover
Germany
