The following data is part of a premarket notification filed by 21 Equipment S.r.l. with the FDA for C.c. Life 21.
| Device ID | K213295 |
| 510k Number | K213295 |
| Device Name: | C.C. LIFE 21 |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | 21 Equipment S.R.L. Piazza Bodoni 3 Torino, IT 10123 |
| Contact | Dolores Moretto |
| Correspondent | Dolores Moretto 21 Equipment S.R.L. Piazza Bodoni 3 Torino, IT 10123 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-01 |
| Decision Date | 2022-11-17 |