The following data is part of a premarket notification filed by Medicis Technologies Corporation with the FDA for Lipsonix(r) System Model 2.
| Device ID | K112626 |
| 510k Number | K112626 |
| Device Name: | LIPSONIX(R) SYSTEM MODEL 2 |
| Classification | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
| Applicant | MEDICIS TECHNOLOGIES CORPORATION 11818 NORTH CREEK PARKWAY N. Bothell, WA 98011 |
| Contact | Michael A Hoffman |
| Correspondent | Michael A Hoffman MEDICIS TECHNOLOGIES CORPORATION 11818 NORTH CREEK PARKWAY N. Bothell, WA 98011 |
| Product Code | OHV |
| CFR Regulation Number | 878.4590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-09 |
| Decision Date | 2011-10-20 |
| Summary: | summary |