K171242 is an FDA 510(k) clearance for the Alma LipoFlow System. This device is classified as a System, Suction, Lipoplasty (Class II - Special Controls, product code MUU).
Submitted by Alma Lasers, Inc. (Buffalo Grove, US). The FDA issued a Cleared decision on July 14, 2017, 78 days after receiving the submission on April 27, 2017.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5040. See Federal Register Notice At 86 Fr 50887 consolidation Of Devices That Process Autologous Human Cells, Tissues, And Cellular And Tissue-based Products At The Point Of Care To Produce A Therapeutic Article (frn) (fda-2021-n-0881)..
| 510(k) Number | K171242 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2017 |
| Decision Date | July 14, 2017 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MUU - System, Suction, Lipoplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5040 |
| Definition | See Federal Register Notice At 86 Fr 50887 consolidation Of Devices That Process Autologous Human Cells, Tissues, And Cellular And Tissue-based Products At The Point Of Care To Produce A Therapeutic Article (frn) (fda-2021-n-0881). |