Device class
Class II
Regulation 878.5040
Total clearances
5
2020-04-14 → 2022-03-16
Definition
What is System, Suction, Lipoplasty
See Federal Register Notice at 86 FR 50887 Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care to Produce a Therapeutic Article (FRN) (FDA-2021-N-0881).
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.5040
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Syntr Health Technologies, Inc. |
1 |
0 |
2021-07-02 |
|
Puregraft, LLC |
1 |
0 |
2020-04-14 |
|
Lifecell Corporation |
1 |
0 |
2020-05-28 |
|
Millennium Medical Technologies Inc (Dba Cellmyx) |
1 |
0 |
2022-03-16 |
|
Bsl Co., Ltd. |
1 |
0 |
2021-03-11 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 15876 |
CPT
|
— |
High
|
CPT for liposuction (lipectomy) including suction-assisted technique |
| 15877 |
CPT
|
— |
Medium
|
CPT for liposuction each additional contiguous area |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2022-03-16 |
K210528 |
Millennium Medical Technologies Inc (Dba Cellmyx)
|
IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit |
| 2021-07-02 |
K203800 |
Syntr Health Technologies, Inc.
|
SyntrFuge System |
| 2021-03-11 |
K202443 |
Bsl Co., Ltd.
|
Smart Kit Basic, Smart Kit Pro |
| 2020-05-28 |
K193539 |
Lifecell Corporation
|
REVOLVE ENVI 600 Advanced Adipose System |
| 2020-04-14 |
K193363 |
Puregraft, LLC
|
Dermapose Refresh |