FDA-Device2025-05-07Class II
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: No
Olympus Corporation of the Americas
Hazard
Preset treatment parameters are not consistently being used in accordance with the IFU.
Sold states
Worldwide distribution - US Nationwide and the countries of AU, CA, SG, DE, JP, HK.
Affected count
189
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: No
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1715-2025Don't want to check this manually?
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