The following data is part of a premarket notification filed by Lysonix, Inc. with the FDA for Lysonix Suction Lipoplasty System.
| Device ID | K980771 |
| 510k Number | K980771 |
| Device Name: | LYSONIX SUCTION LIPOPLASTY SYSTEM |
| Classification | System, Suction, Lipoplasty |
| Applicant | LYSONIX, INC. 1170 MARK AVE. Carpinteria, CA 93013 |
| Contact | Ronald F Lagerquist |
| Correspondent | Ronald F Lagerquist LYSONIX, INC. 1170 MARK AVE. Carpinteria, CA 93013 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-27 |
| Decision Date | 1998-07-13 |
| Summary: | summary |