FDA-Device2024-06-12Class II
Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone.
Newport Corp
Hazard
According to 21 CFR 1040.10(f)(4), 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. However, the key of the subject laser products can be removed from key switch and the laser remains on. This is a safety concern.
Sold states
US Nationwide
Affected count
19
Manufactured in
Unknown Street, N/A, Ivine, CA, United States
Products
Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1946-2024Don't want to check this manually?
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