FDA.reportPublic FDA data

Cosmopen

Primary DI
G589CPMNT030
Brand
Cosmopen
Company
CosmoFrance
Model
Cosmopen Tips -Type A
Catalog number
CPMNT030
Published
2024-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GFEBrush, Dermabrasion, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFEBrush, Dermabrasion, PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G589CPMNT030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dermabrasion brush, rotaryA device with wire bristles that is rotated in a power-driven tool to plane the skin (surgical removal of the epidermis and as much of the dermis as necessary) to remove scars, tattoos, pigmented nevi, fine wrinkles, or other irregularities. This is a reusable device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
015144539
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G589DS22G501DermaSculptDS22G502026-04-13
G589DS22G701DermaSculptDS22G702026-04-13
G589DS23G301DermaSculptDS23G302026-04-13
G589DS23G401DermaSculptDS23G402026-04-13
G589DS23G501DermaSculptDS23G502026-04-13
G589DS25G401DermaSculptDS25G402026-04-13
G589DS25G501DermaSculptDS25G502026-04-13
G589DS27G251DermaSculptDS27G252026-04-13
G589DS27G401DermaSculptDS27G402026-04-13
G589DS27G501DermaSculptDS27G502026-04-13
G589DS30G251DermaSculptDS30G252026-04-13
G589EZ2K1EZPRFEZ2KEZ2K2025-03-04
G589EZ4K1EZPRFEZ4KEZ4K2025-03-04
G58927G04EZINJECT1EZINJECTEZINJECT2024-02-26
G589EZ4K4EZPRFEZ4K2024-02-23
G589EZGEL1EZGELEZ2K2024-02-23
G589EZ2K2EZPRFEZ2KEZ2K2024-02-23
D20230209EZPRFEZ4K2024-02-23
D20230815EZGELEZ2K2024-02-23

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08053782383733T-FACEB&M SRL MARKETING NEL BENESSEREGFE2026-03-25
00810007534794Hydrafacial™ Elite System, 240V INTERNATIONALHydrafacial LLCGFE2026-03-13
00850017374225Zaffiro IR Treatment Body ApplicatorNEAUVIA NORTH AMERICA, INC.GFE2026-02-11
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00817495025414Glace Candela CorporationGFE2025-10-07
00817495025421Glace Candela CorporationGFE2025-10-07
00817495025438Glace Candela CorporationGFE2025-10-07
G050DOXYLIGHTIONIX0OXYLIGHTRAJA MedicalGFE2025-09-24
05391540830826Préime DermaFacialEMA AESTHETICS LIMITEDGFE2025-09-15
00810007534756Hydrafacial™ Lip TipHydrafacial LLCGFE2025-07-16
00810007534763HydraScalp™ Tip, Purify, 6-PackHydrafacial LLCGFE2025-07-16
00810007534770HydraScalp™ Tip, Nourish, 6-PackHydrafacial LLCGFE2025-07-16
00198715351606CANLASE-Alexandrite and Nd: Yag laser Canadian Pioneer Medical Technology CorporationGFE2025-07-02