510(k) K210528
- Device
- IntelliFat Disposable Adipose Tissue Harvesting And Transfer Kit, IntelliFat Body On Demand (BOD) Kit
- Applicant
- Millennium Medical Technologies Inc (DBA Cellmyx)
- 510(k) number
- K210528
- Product code
- MUU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-03-16
- Date received
- 2021-02-23
- Regulation
- 878.5040
- Classification name
- System, Suction, Lipoplasty
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Wangzhong Sheng
- Address
- 6352 Corte De Abeto, Suite A Carlsbad CA US 92011 92011
FDA Registration Numbers#
- 1058584
- 3016467822
- 3011423170
- 3006053983
- 3006798004
- 1211566
- 2024024
- 1222928
- 1649518
- 2032809
- 3011710821
- 1423662
- 3021284635
- 3011707889
- 3009882464
- 3012102437
- 2219920
- 3010742783
- 3008717566
- 1420032
- 3008719017
- 3012441529
- 3009420598
- 3017791237
- 1220477
- 3010173425
- 1054811
- 2030624
- 1066491
- 1313525
- 3007137651
- 1222993
- 3010531069
- 2020601
- 3004167969
- 1649660
- 2953359
- 3008624479
- 1720734
- 3016080683
- 1937141
Source Documents#
Other 510(k) Records For Product Code MUU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203800 | SyntrFuge System | Syntr Health Technologies, Inc. | 2021-07-02 |
| K202443 | Smart Kit Basic, Smart Kit Pro | Bsl Co., Ltd. | 2021-03-11 |
| K193539 | REVOLVE ENVI 600 Advanced Adipose System | Lifecell Corporation | 2020-05-28 |
| K193363 | Dermapose Refresh | Puregraft, LLC | 2020-04-14 |
| K182732 | JTL-250-01 | Jointechlabs, Inc. | 2019-11-18 |
| K191564 | Progenikine Concentrating System 25 mL System | Emcyte Corporation | 2019-11-07 |
| K190386 | KTA Adipose Treatment Kit | Stemics S.A.S | 2019-10-10 |
| K190278 | AuraGen 123 Suction Lipoplasty System (A123) | Auragen Aesthetics, LLC | 2019-05-03 |
| K172717 | Automatic Tissue Processing Unit | Bsl Co. | 2018-05-25 |
| K172714 | LipiVage | Genesis Biosystems, Inc. | 2017-12-08 |
| K163647 | Revolve Envi 600 Advanced Adipose System | Lifecell Corporation | 2017-08-25 |
| K171242 | Alma LipoFlow System | Alma Lasers, Inc. | 2017-07-14 |
| K171135 | Lipogems System | Lipogems International Spa | 2017-05-18 |
| K170449 | Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection | Millennium Medical Technologies, Inc. | 2017-03-31 |
| K161372 | The Red Head Collection Device, The Jordy Connection System | Miami Fat Supply | 2017-02-24 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases