FDA.reportPublic FDA data

Vortex Peel

Primary DI
00667259001730
Brand
Vortex Peel
Company
Silhouet-Tone Corporation
Model
411420
Published
2018-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00667259001730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00667259001730006672590017306672590017300667259001730

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
1-866-340-9456info@silhouettone.com

Regulatory Flags#

DUNS number
242049828
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00667259004007Laguna Edge (2M)4120052025-11-12
00667259003963EVOLUTION XHD4110272025-07-09
00667259003970EVOLUTION ST3504111032025-07-09
00667259001952Soli-Lite LG2 Spectra4115602018-08-24
00667259001600PR Cell 2G4113212018-08-24
00667259003871ELITE PLATINUM LINAK (BI-V)4122682022-07-19
00667259001563ST2504111012018-08-24
00667259003796EVOLUTION 7HD SEQUENTIAL4110172018-09-17
00667259003901ELITE SERIE MD-100 W/O Accessories Table4122522021-09-09
00667259003918ELITE SERIE MD-100-With 2 Arm Support Table4122532021-09-09
00667259003925ELITE SERIE MD-100-With 2 Stirrups Table4122542021-09-09
00667259003932ETNA TABLE (110V) 27 '' 2'' CUSHION WITH HEADREST4127002021-09-09
00667259003949ETNA SBF TABLE (110V) 27'' 2'' CUSHION WITH HEADREST4127162021-09-09
00667259003956ETNA SBF TABLE (110V) 27'' 4'' CUSHION WITH HEADREST4127182021-09-09
00667259003895Soli-Lite LG4 Galileo4115692020-08-17
00667259000030Laguna Mist Flex with Armrest 230V4120044120042017-06-16
00667259000016Laguna Mist 29' 230V4120024120022017-06-16
00667259000443Laguna Mist Flex with Armrest 230V4120044120042017-06-16
00667259000054Laguna Mist 32'' 230V4120144120142017-06-16
00667259003819ELITE SERIE MD-100-With 2 (Stirups & Arm Support) Table4122552019-04-25

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