The following data is part of a premarket notification filed by Bios S.r.l. with the FDA for Family Of Radiofrequency System (biorevital Rf Med, Thermismooth 250).
| Device ID | K151296 |
| 510k Number | K151296 |
| Device Name: | Family Of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| 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 | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-15 |
| Decision Date | 2015-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08052049500111 | K151296 | 000 |
| 08052049500104 | K151296 | 000 |
| 08052049500050 | K151296 | 000 |
| 08052049500043 | K151296 | 000 |
| 08052049500005 | K151296 | 000 |