IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit
FDA 510(k) clearance K210528 · decided 2022-03-16
Clearance details
- K-number
- K210528
- Device name
- IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit
- Applicant
- Millennium Medical Technologies Inc (Dba Cellmyx)
- Decision
- Substantially Equivalent
- Date received
- 2021-02-23
- Decision date
- 2022-03-16
- Days to decision
- 386 days
- Clearance type
- Traditional
- Product code
- MUU
- Device class
- 2
- Regulation number
- 878.5040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SyntrFuge System (K203800) | Syntr Health Technologies, Inc. | 2021-07-02 |
| Smart Kit Basic, Smart Kit Pro (K202443) | Bsl Co., Ltd. | 2021-03-11 |
| REVOLVE ENVI 600 Advanced Adipose System (K193539) | Lifecell Corporation | 2020-05-28 |
| Dermapose Refresh (K193363) | Puregraft, LLC | 2020-04-14 |
| JTL-250-01 (K182732) | Jointechlabs, Inc. | 2019-11-18 |
| Progenikine Concentrating System 25 mL System (K191564) | Emcyte Corporation | 2019-11-07 |
| KTA Adipose Treatment Kit (K190386) | Stemics S.A.S | 2019-10-10 |
| AuraGen 123 Suction Lipoplasty System (A123) (K190278) | Auragen Aesthetics, LLC | 2019-05-03 |
| Automatic Tissue Processing Unit (K172717) | Bsl Co. | 2018-05-25 |
| LipiVage (K172714) | Genesis Biosystems, Inc. | 2017-12-08 |
| Revolve Envi 600 Advanced Adipose System (K163647) | Lifecell Corporation | 2017-08-25 |
| Alma LipoFlow System (K171242) | Alma Lasers, Inc. | 2017-07-14 |
Recalls involving this device
No recalls on record reference this clearance.