FDA.reportPublic FDA data

Zaffiro IR Treatment Applicator

Primary DI
00850017374065
Brand
Zaffiro IR Treatment Applicator
Company
NEAUVIA NORTH AMERICA, INC.
Model
ZIR
Catalog number
300-1104
Device description
Applicator to perform a non-invasive, thermo-lifting with the Zaffiro System
Published
2020-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
00850017374065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017374065008500173740658500173740650850017374065

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

Contacts#

Phone, Email table
PhoneEmail
984-777-5292misty@neauvia-us.com
984-777-5296joy@neauvia-us.com

Regulatory Flags#

DUNS number
117030786
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850017374225Zaffiro IR Treatment Body ApplicatorZIR300-11072026-02-11
00850017374188LaserMe100-1600100-16002023-08-15
00850017374201EpilMe System300-16012022-10-03
00850017374218EpilMe Applicator300-17012022-10-03
00850017374126Sectum System100-13012021-09-27
00850017374133Sectum Precise (Face) Applicator300-13022021-09-27
00850017374140Sectum Body Applicator300-13012021-09-27
00850017374157Sectum Foot Switch300-13062021-09-27
00850017374164Sectum Cable Body Applicator300-13082021-09-27
00850017374171Sectum Cable Precise (Face) Applicator300-13102021-09-27
00850017374003Plasma IQ SystemPLK-755100-12002020-09-14
00850017374010Plasma IQ Electrode Straight (1 piece)AEP-101200-12012020-09-14
00850017374027Plasma IQ Electrode Straight (10 piece)AES-101200-12022020-09-14
00850017374034Plasma IQ Docking StationPCG-724300-12012020-09-14
00850017374041Plasma IQ HandpiecePLA-752300-12022020-09-14
00850017374102Plasma IQ Electrode Curved (1 piece)AEP-102200-12032020-09-14
00850017374119Plasma IQ Electrode Curved (10 piece)AES-102200-12042020-09-14
00850017374096NPure System100-15002021-09-24
00850017374072Zaffiro WP Treatment ApplicatorZWP300-11022020-09-14
00850017374089Zaffiro SystemZ200NG100-11002020-09-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
00860009525108MediSpaMEDICREATIONS LLCGFE2026-02-11
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