—#218672

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

FDA product code: GEX — Powered Laser Surgical Instrument
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K242191
Affected lot / 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;

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

On February 27, 2026 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Examine your inventory and identify any of the affected devices listed in the attachment. 2. Olympus requests that you acknowledge receipt of this letter through our recall web portal. 3. Olympus representatives will begin contacting customers to coordinate the service of affected unit(s). In the meantime, you may continue using your SOLTIVE Laser until the service is completed. Olympus will replace the 24V power supply module at no charge to you. Note: Any issues beyond the replacement of the 24V module in this corrective action will follow the standard SOLTIVE Laser repair process and your service contract, if applicable. 4. If you have further distributed the affected products, please forward this notice to other users who may be impacted.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Chile, Europe, Singapore, Australia, and Hong Kong.

Timeline

Recall initiated: 2026-02-27
Posted by FDA: 2026-03-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218672. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.