IPGTFL-02

The IPGTFL-02 is a desktop thulium fiber laser system used with surgical fibers to perform incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue in urology, lithotripsy, gastroenterology, and gynecology procedures. It operates at up to 60 watts with continuous wave and pulsed modes, and delivers laser energy through flexible optical fibers to the treatment site with or without an endoscope.

Both the IPGTFL-02 and predicate are thulium fiber lasers with identical wavelength (1920–1960 nm), patient-contacting fiber materials, and sterilization methods. The IPGTFL-02 replaces the predicate's 'Assistant Mode' with 'Guided Mode' using flow rate instead of stone size for parameter selection. It adds three new advanced power modes (Fragmentation Pulse, Minimal Carbonization Pulse, Enucleation Pulse) similar to the predicate's Minimal Retropulsion Pulse, and introduces StoneSense technology to detect stone versus non-stone contact and prevent unwanted laser emission.

IEC 60601-1:2005 (medical electrical equipment safety), IEC 60601-1-2:2014 (electromagnetic disturbances), IEC 60601-1-6:2020 (usability), IEC 62366-1:2015 (usability engineering), IEC 62304:2006 (medical device software), IEC 60601-2-22:2019 (surgical laser safety), and IEC 60825-1:2014 (laser product classification and safety).

The IPGTFL-02 is substantially equivalent because it is fundamentally the same thulium fiber laser technology with identical wavelength, power range, fiber materials, and sterilization approach as the predicate. The new features—Guided Mode, advanced power modes, and StoneSense—modify the pulse characteristics or add safety controls without changing the core mechanism of action or intended indications. Ex-vivo testing confirmed the new power modes achieve comparable tissue effects (fragmentation, ablation, coagulation) to the predicate, and StoneSense testing validated its detection capability, confirming safety is not compromised.