IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit
FDA 510(k) K210528 · Millennium Medical Technologies Inc (Dba Cellmyx)
510(k) numberK210528
Submission
- Device name
- IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit
- Applicant
- Millennium Medical Technologies Inc (Dba Cellmyx)
Carlsbad, CA, US - Received
- February 23, 2021
- Decision date
- March 16, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MUU – System, Suction, Lipoplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5040
- Specialty
- General, Plastic Surgery
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).
Other 510(k)s with product code MUU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203800 | SyntrFuge SystemMUU · Traditional | Syntr Health Technologies, Inc. | 07/02/2021SE |
| K202443 | Smart Kit Basic, Smart Kit ProMUU · Traditional | Bsl Co., Ltd. | 03/11/2021SE |
| K193539 | REVOLVE ENVI 600 Advanced Adipose SystemMUU · Traditional | Lifecell Corporation | 05/28/2020SE |
| K193363 | Dermapose RefreshMUU · Traditional | Puregraft, LLC | 04/14/2020SE |
| K182732 | JTL-250-01MUU · Traditional | Jointechlabs, Inc. | 11/18/2019SE |
| K191564 | Progenikine Concentrating System 25 mL SystemMUU · Traditional | Emcyte Corporation | 11/07/2019SE |
| K190386 | KTA Adipose Treatment KitMUU · Traditional | Stemics S.A.S | 10/10/2019SE |
| K190278 | AuraGen 123 Suction Lipoplasty System (A123)MUU · Traditional | Auragen Aesthetics, LLC | 05/03/2019SE |
| K172717 | Automatic Tissue Processing UnitMUU · Traditional | Bsl Co. | 05/25/2018SE |
| K172714 | LipiVageMUU · Traditional | Genesis Biosystems, Inc. | 12/08/2017SE |
Questions and answers
When was IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit cleared by the FDA?
IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit (K210528) received a 510(k) decision of Substantially Equivalent on March 16, 2022, 386 days after the submission was received.
What is the product code of K210528?
The FDA product code is MUU – System, Suction, Lipoplasty, a Class II (moderate risk) device regulated under 21 CFR 878.5040.