PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM
PLASMA SURGICAL LIMITED
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004754983 | 3004754983 | PLASMA SURGICAL INC. | 1 | N | 2026-01-01 | 1125 Northmeadow Pkwy Ste 100 ROSWELL GA US 30076 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| M3970SCP0512H0 | PlasmaJet Neutral Plasma Surgery System - Single-use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System | 1 678 578 4390 | cs@plasmasurgical.com |
| M397LSCG0528H0 | PlasmaJet Neutral Plasma Surgery System - Single-Use Cut/Coagulation Handpiece for Laparoscopic Surgery for the PlasmaJet System | 1 678 578 4390 | cs@plasmasurgical.com |
| M397LSCP0528H0 | PlasmaJet Neutral Plasma Surgery System - Single-Use Cut/Coagulation Handpiece for Laparoscopic Surgery for the PlasmaJet System | 1 678 578 4390 | cs@plasmasurgical.com |
| M397OSCG05070 | PlasmaJet Neutral Plasma Surgery System - Single-Use Cut/Coagulation Handpiece for Open Surgery for PlasmaJet System | 6785784390 | cs@plasmasurgical.com |
| M397OSCG0507H0 | PlasmaJet Neutral Plasma Surgery System - Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System | 1 678 578 4390 | cs@plasmasurgical.com |
| M397PS102130 | PlasmaJet Neutral Plasma Surgery System - PlasmaJet V3 Plus Console System | 6785784390 | rbou@plasmasurgical.com |
| M397PS103130 | PlasmaJet Neutral Plasma Surgery System - PlasmaJet Ultra Plus Console System | 6785784390 | rbou@plasmasurgical.com |
| M397PS104130 | ARION - ARC Generator | 6785784390 | rbou@plasmasurgical.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 23287 | 2017069083 | K253917 | ARION ARC System | GEI | 2026-04-10 |
| 23287 | 1617344286 | K121977 | PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM | GEI | 2012-11-20 |
| 23287 | 1645302584 | K080197 | PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM | GEI | 2008-06-24 |
| 23287 | 1272484299 | K030819 | PLASMAJET SYSTEM | GEI | 2004-08-05 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GEI | 4 | 2026-04-10 |
PLASMA SURGICAL LIMITED
PLASMA SURGICAL, LTD.
PLASMA SURGICAL, LTD.
2026-05-06
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