K212969 is an FDA 510(k) clearance for the Liposaver, a System, Suction, Lipoplasty For Removal (Class II — Special Controls, product code QPB), submitted by Lhbiomed Co., Ltd. (Wonju-Si, KR). The FDA issued a Cleared decision on August 7, 2024, 1056 days after receiving the submission on September 16, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5040.
| 510(k) Number | K212969 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 16, 2021 |
| Decision Date | August 07, 2024 |
| Days to Decision | 1056 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 |