K213534 is an FDA 510(k) clearance for the PHantom Trilogy. This device is classified as a Fat Reducing Low Level Laser (Class II - Special Controls, product code OLI).
Submitted by Resurgeonz, LLC (Merritt Island, US). The FDA issued a Cleared decision on March 11, 2022, 126 days after receiving the submission on November 5, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5400. Non-invasive Reduction In Fat Layer For Body Contouring.
| 510(k) Number | K213534 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2021 |
| Decision Date | March 11, 2022 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OLI - Fat Reducing Low Level Laser |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5400 |
| Definition | Non-invasive Reduction In Fat Layer For Body Contouring |