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Olympus Corporation of the Americas: Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS cont

Medical DevicesSource: FDA (device) · Date: 2026-04-08

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Olympus Corporation of the Americas
Product
Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No
Reason / hazard
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Europe, Singapore, Australia, and Hong Kong.
Recall initiated
2026-02-27
Code info
Laser System: TFL-SLS; UDI: 00821925044135; Component Part: TFL-CSLU; UDI: 00821925044593; Serial #: MDUF190114, MDUF220073, MDUF220331, MDUF220353, MDUF220354, MDUF220356, MDUF220411, MDUF220412, MDUF220413, MDUF220414, MDUF220427, MDUF220451, MDUF220453, MDUF220454, MDUF220455, MDUF220456, MDUF230004, MDUF230005, MDUF230006, MDUF230007, MDUF230076, MDUF230140, MDUF230141, MDUF230163, MDUF230164, MDUF230166, MDUF230167, MDUF230234, MDUF230283, MDUF230284, MDUF230331, MDUF230332, MDUF230361, MDUF230362, MDUF230363, MDUF230364, MDUF230365, MDUF230366, MDUF230411, MDUF230412, MDUF230413;
Product quantity
32 units
Voluntary mandated
Voluntary: Firm initiated
City
Center Valley
State
PA
Country
United States
Event id
98422
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