FDA-Device2025-06-18Class II
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only); 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
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Sold states
Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
Affected count
201 units (100 US, 101 OUS)
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only); 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-1920-2025Don't want to check this manually?
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