FDA-Device2024-08-14Class II
Soltive Premium SuperPulsed Laser System, Model TFL-PLS
Olympus Corporation of the Americas
Hazard
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.
Affected count
1,585 Units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Soltive Premium SuperPulsed Laser System, Model TFL-PLS
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2504-2024Don't want to check this manually?
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