FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Lipogems System
K Number: K161636
·
Decision Nov 4, 2016
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
39
Applicant Total
3
Review Days
143
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Lipogems System
- K Number
- K161636
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lipogems International Spa
- Date Received
- June 14, 2016
- Decision Date
- November 4, 2016
- Product Code
- MUU
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MUU | System, Suction, Lipoplasty | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MUU), ordered by most recent decision date.
IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SyntrFuge System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Smart Kit Basic, Smart Kit Pro
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
REVOLVE ENVI 600 Advanced Adipose System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Dermapose Refresh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
JTL-250-01
FDA 510(k)
FDA Class 2
·General, Plastic Surgery