FDA.reportPublic FDA data

EUROMI

Primary DI
03701416203401
Brand
EUROMI
Company
Euromi
Model
Eva sp6 - 110V
Catalog number
1114sp616110V
Device description
Eva sp® 6 allows not only a quantitative nutational infrasonic infiltration but also a nutational infrasonic liposculpture.The advantages of the Eva sp® 6 are numerous:• Connective tissues are preserved: better skin retraction, less bleeding, oedema, bruising and pain. The recovery time is shorter.• The infiltration is constant, deep, homogeneous and controlled, regardless of the type of fat.• The infrasonic frequency (
Published
2025-08-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe

Product Codes#

Code, Name table
CodeName
QPBSystem, Suction, Lipoplasty For Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QPBSystem, Suction, Lipoplasty For RemovalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010311000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010311000LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICEEuromi S.A2001-06-29QPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701416203401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701416203401037014162034013701416203401

GMDN Terms#

Term, Definition table
TermDefinition
Liposuction systemAn assembly of devices designed specifically to aspirate subcutaneous fat from the body by means of suction during a liposuction/lipectomy procedure. The system consists of an electrically-powered suction pump, typically with collection containers, tubing, and microbial/hydrophobic filters, and includes patient contact devices (e.g., handpiece/tip, cannula). The pump generates negative pressure for aspiration of fat through the patient contact device, which is inserted subcutaneously into the fat layer, and into the collection containers.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
505804302
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701416200066Euromi1214LMEW-42501214LMEW-42502025-10-10
03701416200110Euromi1214LMEI-52001214LMEI-52002025-10-10
03701416200134Euromi1214LMEW-53001214LMEW-53002025-10-10
03701416200172Euromi1214LMEI-52501214LMEI-52502025-10-10
03701416200233Euromi1214LMEW-43501214LMEW-43502025-10-10
03701416200776Euromi1214LMEI-43001214LMEI-43002025-10-10
03701416201339Euromi1214LVITI-52001214LVITI-52002025-10-10
03701416201377Euromi1214LMEW-43001214LMEW-43002025-10-10
03701416201421Euromi1214LMEW-52001214LMEW-52002025-10-10
03701416201445Euromi1214LMEW-41501214LMEW-41502025-10-10
03701416201643Euromi1214LVITW-4.52501214LVITW-4.52502025-10-10
03701416201650Euromi1214LVITW-4.53001214LVITW-4.53002025-10-10
03701416201711Euromi1214LMEI-53501214LMEI-53502025-10-10
03701416201889Euromi1214LMEW-52501214LMEW-52502025-10-10
03701416201964Euromi1214LMEW-53501214LMEW-53502025-10-10
03701416202015Euromi1214LVITW-4.52001214LVITW-4.52002025-10-10
03701416202022Euromi1214LVITW-4.53501214LVITW-4.53502025-10-10
03701416202046Euromi1214LMEI-53001214LMEI-53002025-10-10
03701416202084Euromi1214LMEW-42001214LMEW-42002025-10-10
03701416202121Euromi1214LILW-43001214LILW-43002025-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607151050627AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 33cm length, 3 ringsAPYX MEDICAL CORPORATIONQPB2026-06-26
00607151050634AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 26cm length, 3 ringsAPYX MEDICAL CORPORATIONQPB2026-06-26
00607151050641AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 33cm length, 1 ringAPYX MEDICAL CORPORATIONQPB2026-06-26
00840329838225BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.QPB2026-06-08
00607151051006AYON™ Power Liposuction Tubing AdaptorAPYX MEDICAL CORPORATIONQPB2026-05-14
00607151057008AYON™ Power Liposuction HandpieceAPYX MEDICAL CORPORATIONQPB2026-05-14
00607151057015AYON™ Power Liposuction CableAPYX MEDICAL CORPORATIONQPB2026-05-14
08800028800031LSSA (NP-200)NewpongQPB2026-05-06
03701416200035EUROMIEuromiQPB2025-08-27
03701416203388EUROMIEuromiQPB2025-08-27
00847399017413MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017420MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017437MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017444MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017451MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017468MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017475MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017482MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017499MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017505MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017512MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399018960MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
04260170880048WAL applicatorHuman Med AGQPB2025-07-30
04260170880505WAL applicatorHuman Med AGQPB2025-07-30
04260170880826WAL CannulaHuman Med AGQPB2025-07-30
04260170880864WAL CannulaHuman Med AGQPB2025-07-30
04260170880888WAL CannulaHuman Med AGQPB2025-07-30
04260170880901WAL CannulaHuman Med AGQPB2025-07-30
04260170880925WAL CannulaHuman Med AGQPB2025-07-30
04260170880949WAL CannulaHuman Med AGQPB2025-07-30