The following data is part of a premarket notification filed by Bios S.r.l with the FDA for Superbium.
| Device ID | K153229 |
| 510k Number | K153229 |
| Device Name: | Superbium |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOS S.R.L VIA GUIDO ROSSA, 10/12 Vimodrone, IT I-20090 |
| Contact | Riccardo Pisati |
| Correspondent | Riccardo Pisati BIOS S.R.L VIA GUIDO ROSSA, 10/12 Vimodrone, IT I-20090 |
| Product Code | GEX |
| Subsequent Product Code | ONF |
| Subsequent Product Code | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-06 |
| Decision Date | 2016-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08052049500012 | K153229 | 000 |