← Every firm

Pacific Lasertech, LLC FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
25-LHP-828, HeNe Laser System, 35 mWClass IIMar 1, 2024These laser products fail to comply with 21 CFR 1040.10(f)(4
25-LHP-928, HeNe Laser System, 25 mWClass IIMar 1, 2024These laser products fail to comply with 21 CFR 1040.10(f)(4
N-LHP-928, HeNe Laser System, 35 mWClass IIMar 1, 2024These laser products fail to comply with 21 CFR 1040.10(f)(4

Related datasets