The following data is part of a premarket notification filed by Genesis Biosystems, Inc. with the FDA for Lipivage.
| Device ID | K172714 |
| 510k Number | K172714 |
| Device Name: | LipiVage |
| Classification | System, Suction, Lipoplasty |
| Applicant | Genesis Biosystems, Inc. 1500 Eagle Court Lewisville, TX 75057 |
| Contact | Jim Lafferty |
| Correspondent | Stuart R. Goldman Emergo Global Consulting , LLC 2500 Bee Cave Road, Bldg 1, Suite 300 Austin, TX 78746 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-08 |
| Decision Date | 2017-12-08 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LIPIVAGE 85839976 not registered Dead/Abandoned |
Genesis Biosystems, Inc. 2013-02-04 |
![]() LIPIVAGE 78544352 3095184 Live/Registered |
Genesis Biosystems, Inc. 2005-01-08 |