25-LHP-928, HeNe Laser System, 25 mW
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.
US Nationwide Distribution
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2976-2024