FDA.reportPublic FDA data

ST Applicator

Primary DI
07290016746310
Brand
ST Applicator
Company
VIORA LTD
Model
VRE2001
Catalog number
VRE2001
Device description
ST Applicator
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating
ISAMassager, Therapeutic, Electric
NUVMassager, Vacuum, Light Induced Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2
ISAMassager, Therapeutic, ElectricPhysical Medicine1
NUVMassager, Vacuum, Light Induced HeatingGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090221000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090221000REACTION SYSTEMViora , Ltd.2009-07-01NUV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016746310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016746310072900167463107290016746310

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin contouring systemAn assembly of devices that uses a combination of energies to temporarily minimize the manifestation of cellulite and loose or wrinkled skin. It typically consists of an applicator attached to an energy-producing generator and possibly other components. The applicator is applied to the body and may emit radio-frequency [typically in the bands of 1 megahertz (MHz)], infrared light, and/or other forms of energy, to heat skin/subdermal tissues for the production of a smooth-skin appearance. Vacuum may also be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8884151192CustomerCareUSA@vioramed.com

Regulatory Flags#

DUNS number
514612758
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016746044V-IPL HP BasicVTL43000VTL430002016-09-23
07290016746051V-IPL HP FullVTL43040VTL430402016-09-23
07290016746068V-IPL HP FullVTL43060VTL430602016-09-23
07290016746402V-FR HandpieceV-FR20022026-04-19
07290016746501V-FR TipVTO20022026-04-19
07290016746563V-IPL Optic set Full 6 filtersVTL43050-6VTL43050-62025-12-22
07290016746662V-FC TipVTL48014VTL480142025-05-22
07290016746433ST Single Use TipAS47010AS470102025-06-03
07290016746457V-ST Single Use tipAS47000AS470002025-06-03
07290016746754Treatment Kit 2.0GM00030 (US)GM00030 (US)2025-06-03
07290016746464V-ST Single Use tipAS47000AS470002025-06-03
07290016746471V-VR HandpieceVTL48010VTL480102025-06-03
17290016746652V-FC TipAS70028AS700282025-05-22
07290016746785V-FC Pro FullVTL48015-FVTL48015-F2025-09-01
07290016746808V-FC Pro TipVTL48018VTL480182025-09-01
07290016746815V-FC Pro HandpieceVTL48017VTL480172025-09-01
07290016746716ConsoleMM40000-USMM40000-US2025-05-22
07290016746723ApplicatorMM01000-USMM01000-US2025-05-22
07290016746730TrolleyMM60000-USMM60000-US2025-05-22
07290016746747Disposable Delivery NozzleMM05000-2.0 (US)MM05000-2.0 (US)2025-05-22

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