The following data is part of a premarket notification filed by Lifecell Corporation with the FDA for Revolve Envi 600 Advanced Adipose System.
| Device ID | K193539 |
| 510k Number | K193539 |
| Device Name: | REVOLVE ENVI 600 Advanced Adipose System |
| Classification | System, Suction, Lipoplasty |
| Applicant | LifeCell Corporation One Millennium Way Branchburg, NJ 08876 |
| Contact | Bozhana Hegarty |
| Correspondent | Bozhana Hegarty LifeCell Corporation One Millennium Way Branchburg, NJ 08876 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-20 |
| Decision Date | 2020-05-28 |