All Lee Laser Series 800 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 800 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
Specially designed Series 800 Lasers that bear the "CE" designator as part of the model
number 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-B Emission Standard for Industrial, Scientific and Medical RF
Equipment for Class B
B. EN 50082-2 Generic Immunity for Heavy Industrial Environment
Series 800 Nd:YAG Lasers were tested against the EMC Directive, 89/336/EEC, and verified
by D.L.S. Electronic Systems, Inc., Wheeling, Illinois, on October 20, 1995, under the
supervision of TUV Rheinland of North America, Inc. The Product Safety Directive (LVD),
73/23 EEC, was verified by TUV Rheinland of North America in March 1996. A Declaration
of Conformity is included in the Operation Manual of all Series 800 "CE" lasers.
The EMC Directive, 89/336/EEC, is contained as a prerequisite of the Product Safety Directive
(LVD), 73/23/EEC. All Series 800 Lasers manufactured after March 1996, including non-"CE"
lasers, meet the provisions of the Product Safety Directive.
Series 800 Lasers without CE Mark
Outside of Europe, Lee Laser delivers our Series 800 Lasers to users in most of the
industrially developed countries of the world. This, of course, includes the United States.
These lasers do not require the CE Mark certification.
All Series 800 Lasers that do not bear the CE suffix to the model number have been
designed to meet the requirements of the Product Safety Directives of the European
Economic Union (EEU) as are listed below:
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
Compliance of the Series 800 lasers with the Product Safety Directive (LVD), 73/23 EEC, was
verified by TUV Rheinland of North America in March 1996.
