Plasma Surgical, Ltd.

Medical device manufacturer in Roswell, GA.

4510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K253917ARION ARC SystemGEI · Traditional 04/10/2026SE
K121977Plasmajet Neutral Plasma Surgery SystemGEI · Traditional 11/20/2012SE
K080197Plasmajet Neutral Plasma Surgery SystemGEI · Traditional 06/24/2008SE
K030819Plasmajet SystemGEI · Traditional 08/05/2004SE

Recalls

RecallProductInitiated
Z-1794-2012 Class IIPlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System)…Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible… 04/27/2012Terminated