All Lee Laser Series 600 Nd:YAG Lasers meet the design and manufacturing requirements of
Title 21, Code of Federal Regulations, Subchapter J which is the U.S. Government regulation
that covers U.S. laser products, and is enforced by the Center for Devices and Radiological
Health (CDRH). The CDRH Accession Number assigned to the Series 600 lasers is 8510464.
U.S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Devices and Radiological Health
2098 Gaither Road
Rockville, MD 20850
Compliance with European "CE Mark" Directives
Series 600 Lasers are designed and manufactured in compliance with the following directives
of the European Economic Union (EEU):
I. Product Safety Directive (LVD), 73/23 EEC
A. EN 60825-1 Radiation Safety of Laser Products (IEC 825)
B. EN 60204-1 Electrical Equipment of Industrial Machines (IEC 204)
C. EN 292-1 Safety of Machinery, General Provisions
D. EN 418 Safety of Machinery, Emergency Stop
II. EMC Directive, 89/336/EEC
A. EN 55011-A Emission Standard for Industrial, Scientific and Medical RF
Equipment for Class A
B. EN 50082-2 Generic Immunity for Heavy Industrial Environment
A Declaration of Conformity is included in the Operation Manual of all Series 600 and Series
LDP lasers that are shipped to EU countries.
The EMC Directive, 89/336/EEC, is contained as a prerequisite of the Product Safety Directive
(LVD), 73/23/EEC.
