The following data is part of a premarket notification filed by Bios S.r.l. with the FDA for Nuera Tight Rf, Nuera Tight Rf Plus.
| Device ID | K210867 |
| 510k Number | K210867 |
| Device Name: | NuEra Tight RF, NuEra Tight RF Plus |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | BIOS S.r.l. Via Guido Rossa 10/12 Vimodrone, IT 20090 |
| Contact | Eliana Russo |
| Correspondent | Eliana Russo BIOS S.r.l. Via Guido Rossa 10/12 Vimodrone, IT 20090 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-23 |
| Decision Date | 2021-04-21 |