REVOLVE ENVI 600 Advanced Adipose System
FDA 510(k) K193539 · Lifecell Corporation
510(k) numberK193539
Submission
- Device name
- REVOLVE ENVI 600 Advanced Adipose System
- Applicant
- Lifecell Corporation
Branchburg, NJ, US - Received
- December 20, 2019
- Decision date
- May 28, 2020
- 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).
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210528 | IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On…MUU · Traditional | Millennium Medical Technologies Inc (Dba Cellmyx) | 03/16/2022SE |
| 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 |
| 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 |
More from Genesis Biosystems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K163647 | Revolve Envi 600 Advanced Adipose SystemMUU · Traditional | 08/25/2017SE |
| K162752 | ARTIA Reconstructive Tissue Matrix PerforatedFTM · Traditional | 02/24/2017SE |
| K150712 | LTM-Perforated Surgical MeshFTM · Traditional | 07/02/2015SE |
| K142326 | HP Tissue MatrixFTM · Traditional | 12/23/2014SE |
| K130817 | LTN - Laparoscopic Surgical MeshOXK · Special | 04/17/2013SE |
| K112534 | Lifecell Tissue ExpanderLCJ · Traditional | 08/10/2012SE |
| K121289 | Ltm-Labaroscopic Surgical MeshOXK · Traditional | 08/03/2012SE |
| K082176 | Ltm-Bps Surgical MeshFTM · Traditional | 11/14/2008SE |
| K082103 | LTM Wound DressingKGN · Traditional | 10/08/2008SE |
| K080353 | Ltm-T Surgical MeshFTL · Traditional | 04/03/2008SE |
Questions and answers
When was REVOLVE ENVI 600 Advanced Adipose System cleared by the FDA?
REVOLVE ENVI 600 Advanced Adipose System (K193539) received a 510(k) decision of Substantially Equivalent on May 28, 2020, 160 days after the submission was received.
What is the product code of K193539?
The FDA product code is MUU – System, Suction, Lipoplasty, a Class II (moderate risk) device regulated under 21 CFR 878.5040.