PACIFIC LASERTECH, LLC
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for PACIFIC LASERTECH, LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-09-18FDA-DeviceClass IIN-LHP-928, HeNe Laser System, 35 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.
- 2024-09-18FDA-DeviceClass II25-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.
- 2024-09-18FDA-DeviceClass II25-LHP-828, HeNe Laser System, 35 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.
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