Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP
LED SpA
LED SPA
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006411077 | 3006411077 | LED SPA | 1 | N | 2026-01-01 | via Selciatella, 40 Aprilia Latina IT 04011 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 312066 | 1964953076 | K220138 | Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP | GEI | 2022-10-05 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GEI | 1 | 2022-10-05 |
PMN#
GUDID#
SURTRON - SURTRON device model 160HF is an ElectroSurgical Unit including monopolar and bipolar technology. SURTRON 160HF is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating. Maximum output power is 150W and frequency of 4MHz.
2023-10-29
SURTRON - SURTRON device model 400HP is an ElectroSurgical Unit including monopolar and bipolar technology. SURTRON 400HP is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating. Maximum output power is 400W and frequency of 425kHz.
2023-10-29
SURTRON - SURTRON device model 80D is an ElectroSurgical Unit including monopolar. SURTRON 80D is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating. Maximum output power is 80W and frequency of 700kHz.
2023-10-29
SURTRON - SURTRON device model 160 is an ElectroSurgical Unit including monopolar and bipolar technology. SURTRON 160 is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating. Maximum output power is 160W and frequency of 600kHz.
2023-10-29
SURTRON - SURTRON device model 200 is an ElectroSurgical Unit including monopolar and bipolar technology. SURTRON 200 is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating. Maximum output power is 200W and frequency of 600kHz.
2023-10-29