The following data is part of a premarket notification filed by Led Spa with the FDA for Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 Hf, Surtron 400 Hp.
| Device ID | K220138 |
| 510k Number | K220138 |
| Device Name: | Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | LED SpA Via Selciatella, 40 Aprilia, IT 04011 |
| Contact | Amalia Lamberti |
| Correspondent | Amalia Lamberti LED SpA Via Selciatella, 40 Aprilia, IT 04011 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-18 |
| Decision Date | 2022-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852087007607 | K220138 | 000 |
| 00852087007591 | K220138 | 000 |
| 00852087007584 | K220138 | 000 |
| 00852087007577 | K220138 | 000 |