The following data is part of a premarket notification filed by Auragen Aesthetics Llc with the FDA for Auragen 123 Suction Lipoplasty System (a123).
| Device ID | K190278 |
| 510k Number | K190278 |
| Device Name: | AuraGen 123 Suction Lipoplasty System (A123) |
| Classification | System, Suction, Lipoplasty |
| Applicant | AuraGen Aesthetics LLC 11 Dellbrook Road Weston, MA 02493 |
| Contact | Yiannis Monovoukas |
| Correspondent | Randy J. Prebula Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-08 |
| Decision Date | 2019-05-03 |