K220318 is an FDA 510(k) clearance for the PAL Infiltration System. This device is classified as a System, Suction, Lipoplasty For Removal (Class II - Special Controls, product code QPB).
Submitted by Microaire Surgical Instruments, LLC (Charlottesville, US). The FDA issued a Cleared decision on October 14, 2022, 253 days after receiving the submission on February 3, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5040. A Suction Lipoplasty System Is A Device Intended For The Removal Of Adipose Tissue For Purposes Of Aesthetic Body Contouring.
| 510(k) Number | K220318 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2022 |
| Decision Date | October 14, 2022 |
| Days to Decision | 253 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QPB - System, Suction, Lipoplasty For Removal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5040 |
| Definition | A Suction Lipoplasty System Is A Device Intended For The Removal Of Adipose Tissue For Purposes Of Aesthetic Body Contouring |