FDA-Device2021-08-25Class II
Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological surgery
Olympus Corporation of the Americas
Hazard
Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets
Sold states
US Nationwide Distribution Foreign: Canada Australia Japan Hong Kong Europe Singapore
Affected count
408 units
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological surgery
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2294-2021Don't want to check this manually?
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