FDA-Device2024-04-03Class II
SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
Olympus Corporation of the Americas
Hazard
A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
Sold states
Domestic: OUS Only; International distribution in the states of Australia, Chile, Germany, Hong Kong, Japan, New Zealand and Singapore.
Affected count
203 Units (OUS Only)
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1385-2024Don't want to check this manually?
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