K191068 is an FDA 510(k) clearance for the Powersculp laser lipolysis system. This device is classified as a Laser For Disruption Of Adipocyte Cells For Aesthetic Use (Class II - Special Controls, product code PKT).
Submitted by Wuhan Lotuxs Technology Co., Ltd. (East Lake High-Tech Development Zone, Wu, CN). The FDA issued a Cleared decision on July 17, 2019, 86 days after receiving the submission on April 22, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5400. Laser Intended For The Disruption Of Adipocyte Cells Indicated For Body Contouring Or Reduction In Circumference Of Body Areas..
| 510(k) Number | K191068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2019 |
| Decision Date | July 17, 2019 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | PKT - Laser For Disruption Of Adipocyte Cells For Aesthetic Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5400 |
| Definition | Laser Intended For The Disruption Of Adipocyte Cells Indicated For Body Contouring Or Reduction In Circumference Of Body Areas. |