FDA.reportPublic FDA data

AuraGen Aesthetics

Primary DI
00860003492703
Brand
AuraGen Aesthetics
Company
Auragen Aesthetics LLC
Model
100358
Device description
AuraGen 1-2-3 with AuraClens - Lipoaspirate Wash System
Published
2021-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QKLLipoaspirate Washing System For Aesthetic Body Contouring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKLLipoaspirate Washing System For Aesthetic Body ContouringGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1904330

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1904330

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003492703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003492703008600034927038600034927030860003492703

GMDN Terms#

Term, Definition table
TermDefinition
Autologous adipose tissue collection/washing setA collection of sterile devices designed as a closed system for the harvesting and rapid treatment of autologous fat tissue for reinjection back into the patient from which it was taken for aesthetic body contouring. It typically consists of various chambers (e.g., a collection bag, waste material bag, and a cleaned tissue bag), flexible tubing, an intravenous (IV) spike for connection to the washing solutions, and a contiguous filter mesh which dialyses the fat graft. It is used in conjunction with appropriate IV solutions within the sterile field of intervention for plastic and reconstructive surgery and cosmetic surgery. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118060681
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08681877009017Lipocube NanoSTEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
08681877009086Centrifgue Container (15CC)STEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
08681877009093Centrifgue Container (20 CC) STEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
08681877009116Lipocube HybridSTEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
08681877009345Lipocube Hybrid ISTEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
08681877009826Lipocube Hybrid MiniSTEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
00850034511047Puregraft SYNCBimini Technologies LLCQKL2026-02-24
04260170881083FillerCollectorHuman Med AGQKL2025-07-30
04260170881373Disposable Set FillerCollectorHuman Med AGQKL2025-07-30
04260170881403Disposable Set LipoCollector IIIHuman Med AGQKL2025-07-30
04260170881410Drainage Set LipoCollector III PlusHuman Med AGQKL2025-07-30
04260170881427Extraction cannula, LCHuman Med AGQKL2025-07-30
04260170881434Extraction cannulaHuman Med AGQKL2025-07-30
04260170881441Extraction cannulaHuman Med AGQKL2025-07-30
04260170881502Extraction tubeHuman Med AGQKL2025-07-30
04260170881571FillerCollector, Stand, SU, SetHuman Med AGQKL2025-07-30
04260170881076FillerCollectorHuman Med AGQKL2025-07-30
04260170881366FillerCollectorHuman Med AGQKL2025-07-30
14260170881370Disposable Set FillerCollectorHuman Med AGQKL2025-07-30
04260170881380LipoCollector 3, completeHuman Med AGQKL2025-07-30
14260170881400Disposable Set LipoCollector IIIHuman Med AGQKL2025-07-30
14260170881417Drainage Set LipoCollector III PlusHuman Med AGQKL2025-07-30
14260170881424Extraction cannula, LCHuman Med AGQKL2025-07-30
14260170881431Extraction cannulaHuman Med AGQKL2025-07-30
14260170881448Extraction cannulaHuman Med AGQKL2025-07-30
14260170881509Extraction tubeHuman Med AGQKL2025-07-30
14260170881578FillerCollector, Stand, SU, SetHuman Med AGQKL2025-07-30
00860005496709SyntrFuge SystemSyntr Health Technologies, IncQKL2024-10-17
00860005496723SyntrFuge System 30Syntr Health Technologies, IncQKL2024-10-17
00850034511023Puregraft 850 System Twin PackBimini Technologies LLCQKL2024-08-22