Miyachi LMV1000, User Manual

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LMV1000 (G)(E) AIR-COOLED LASER MARKER
990-541 vii
CDRH COMPLIANCE STATEMENT
The Miyachi Unitek LMV1000 and Miyachi Corporation ML-7110A and
ML-9000A Laser Markers are certified to be fully compliant with all
applicable standards and regulations as set forth by the United States of
America’s Health and Human Services (HHS), Food and Drug
Administration (FDA), Center for Devices and Radiological Health
(CDRH), title 21 Code of Federal Regulations (CFR) sections 1002, 1010,
and 1040 for Class IV laser devices.
Reference CDRH Accession number is available upon request.
For details, refer to the following standards.
LMV1000 & ML-7110A-CDRH
Certified to be in compliance with CDRH Standards Part 1040 Sec.
1040.10 “Radiation safety standards for laser equipment”
LMV1000E & ML-7110A-CE
In compliance with EN Standards EN60825-1 “Radiation safety standards
for laser equipment”
LMV1000G & ML-9000A-CDRH
Certified to be in compliance with CDRH Standards Part 1040 Sec.
1040.10 “Radiation safety standards for laser equipment”
LMV1000GE & ML-9000A-CE
In compliance with EN Standards EN60825-1 “Radiation safety standards
for laser equipment”