| Device Type ID | 5752 |
| Device Name | System, Suction, Lipoplasty |
| Regulation Description | Suction Lipoplasty System. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.5040 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MUU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 5752 |
| Device | System, Suction, Lipoplasty |
| Product Code | MUU |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Suction Lipoplasty System. |
| CFR Regulation Number | 878.5040 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALLERGAN, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALMA LASERS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BLACK & BLACK SURGICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CYTORI THERAPEUTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GENESIS BIOSYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INEX | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INGENERON, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
LIFECELL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MICROAIRE | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MICROAIRE SURGICAL INSTRUMENTS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MILLENNIUM | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MILLENNIUM MEDICAL T | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RANFAC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RANFAC, CORP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THIEBAUD SAS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 32 |
Device Emits Odor | 3 |
Fluid Leak | 3 |
Failure To Power Up | 2 |
Material Deformation | 2 |
Appropriate Term/Code Not Available | 2 |
Suction Problem | 1 |
Backflow | 1 |
Electrical /Electronic Property Problem | 1 |
Connection Problem | 1 |
Contamination During Use | 1 |
Decoupling | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Electrical Shorting | 1 |
Mechanical Problem | 1 |
Improper Flow Or Infusion | 1 |
Break | 1 |
Crack | 1 |
Device Damaged Prior To Use | 1 |
| Total Device Problems | 57 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Globalmed Logistix | II | Jan-25-2016 |
| 2 | LifeCell Corporation, A Wholly Owned Subsidiary Of Allergan PLC | II | Mar-01-2018 |
| 3 | Miami Fat Supply, Inc | II | Jun-14-2016 |
| 4 | MicroAire Surgical Instruments, LLC | II | Sep-30-2015 |
| 5 | Shippert Medical Technologies | II | Nov-22-2017 |
| 6 | Terumo BCT, Inc. | II | Nov-30-2016 |