510(k) K010311

Device
LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE
Applicant
EUROMI SA
510(k) number
K010311
Product code
MUU  
Decision
Substantially Equivalent (SESE)
Decision date
2001-06-29
Date received
2001-02-01
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

Related Records

Applicant Contact

Contact
JOSEPH M AZARY
Address
P.O. Box 2156 Huntington CT US 06484 06484

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
03701416203401EUROMIEuromi2025-08-27

Other 510(k) Records For Product Code MUU  

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K202443Smart Kit Basic, Smart Kit ProBsl Co., Ltd.2021-03-11
K193539REVOLVE ENVI 600 Advanced Adipose SystemLifecell Corporation2020-05-28
K193363Dermapose RefreshPuregraft, LLC2020-04-14
K182732JTL-250-01Jointechlabs, Inc.2019-11-18
K191564Progenikine Concentrating System 25 mL SystemEmcyte Corporation2019-11-07
K190386KTA Adipose Treatment KitStemics S.A.S2019-10-10
K190278AuraGen 123 Suction Lipoplasty System (A123)Auragen Aesthetics, LLC2019-05-03
K172717Automatic Tissue Processing UnitBsl Co.2018-05-25
K172714LipiVageGenesis Biosystems, Inc.2017-12-08
K163647Revolve Envi 600 Advanced Adipose SystemLifecell Corporation2017-08-25
K171242Alma LipoFlow SystemAlma Lasers, Inc.2017-07-14
K171135Lipogems SystemLipogems International Spa2017-05-18
K170449Autoclavable 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 protectionMillennium Medical Technologies, Inc.2017-03-31

Legacy Summary

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FDA Review

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