FDA-Device2024-09-18Class II
25-LHP-828, HeNe Laser System, 35 mW
PACIFIC LASERTECH, LLC
Hazard
These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.
Sold states
US Nationwide Distribution
Affected count
4
Manufactured in
215 Bingham Dr # 110, San Marcos, CA, United States
Products
25-LHP-828, HeNe Laser System, 35 mW
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2975-2024Don't want to check this manually?
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