FDA.reportPublic FDA data

Cellfie

Primary DI
07290110123055
Brand
Cellfie
Company
ALMA LASERS LTD.
Model
1
Catalog number
AAVF16042301
Published
2023-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
BK2206680

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK2206680

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290110123055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110123055072901101230557290110123055

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
532283264
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290110123772Handpiece LP Nd:Yag 1064 Cooled for Harmony XL Pro (color cooled gray)1AAHP080315012026-03-02
07290110123741Alma Pixel 30W 120V 50/60Hz Black (Inc)1AACO17062501BA00012025-08-11
07290110123680Pixel CO2 30W 120V 50/60Hz Black (Inc)1AACO17062501BA00012025-07-08
17290110121829Soprano Titanium System 230V1AASP05091845BSR00012022-11-06
17290110122093Hybrid System 30W 120V 50/60 HZ1AACO15061980BDAZ00042021-07-11
17290110122109Hybrid System 70W 120V 50/60 HZ 1AACO15061980BDAZ00032021-07-11
17290110122116ProScan Applicator for Hybrid System1AACO051119602021-07-11
17290110122123Pixel CO2 7x7 & 9x9 Applicator for Hybrid System1AACO280319272021-07-11
17290110122130HyLight 50 VSS Applicator for US Hybrid System1AACO090321802021-07-11
17290110122147HyLight 200 VSS Applicator for US Hybrid System1AACO100321802021-07-11
17290110120785FemiLift Handpiece1AACO171113612016-09-24
17290110120952CO2 New Scanner system 100-120V 30W1AACO010212032016-09-24
17290110120976CO2 New Scanner system 100-120V 70W1AACO010212072016-09-24
17290110121621Trio Diode Laser Module1AASP02031601 2018-09-16
07290110123376ALMA HARMONY CONSOLE1AAHG25102201BR00012023-12-20
07290110123888CO2 LiteScan Applicator FOR INC1AACO030925012025-09-21
07290110122317Accent Prime System 120V For Inc.1AAAP07042201BA00012022-11-22
07290110122324Accent Prime UltraSpeed Applicator for Inc.1AAAP070422112022-11-22
07290110122331Accent Prime MiniSpeed Applicator for Inc.1AAAP070422132022-11-22
07290110122348Accent Prime Ultra Applicator for Inc.1AAAP070422152022-11-22

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