Unitek Miyachi LW250 Operation, Maintenance And Service Manual page 3

CDRH COMPLIANCE STATEMENT
The Unitek Miyachi Corporation LW250 Pulsed
Nd:YAG Laser is 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), standard 21
CFR 1040.10 for Class IV laser devices. Please refer to
CDRH Accession #9311157-03.
LW250 Pulsed Nd: YAG LASER
990-605 REV B: May, 1997 ii