K201731 is an FDA 510(k) clearance for the Diode Laser Body Sculpture 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 Shanghai Apolo Medical Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on September 10, 2020, 78 days after receiving the submission on June 24, 2020.
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 | K201731 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2020 |
| Decision Date | September 10, 2020 |
| Days to Decision | 78 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. |