FDA.reportPublic FDA data

Reaction™

Primary DI
07290016746303
Brand
Reaction™
Company
VIORA LTD
Model
VRE0110
Catalog number
VRE0110
Device description
Reaction™
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
07290016746303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016746303072900167463037290016746303

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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06927753902457MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
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06927753902488MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
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06927753902518MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902525MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902532MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902549MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902556MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902563MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902594MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753902600MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
06927753906059MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
16927753900009MASSAGE CHAIRFu'an Music Dance Electrical Appliance Co., LtdISA2026-10-29
00810140063236RENPHO Foot MassagerJoicom CorporationISA2026-10-27
00810140063243RENPHO Foot MassagerJoicom CorporationISA2026-10-27
06974958310631mitoredlightShenzhen Idea Light LimitedISA2026-10-22
06975981280045RedfySunPlus LED Technology Co., Ltd.ILY2026-10-21
06975981280052RedfySunPlus LED Technology Co., Ltd.ILY2026-10-21
06975981280076RedfySunPlus LED Technology Co., Ltd.ILY2026-10-21
06975981280144RedfySunPlus LED Technology Co., Ltd.ILY2026-10-21
00810140063229Renpho RejuvenJoicom CorporationISA2026-10-20
07090072490000FlexBeamRecharge Health ASILY2026-10-15
00810226442610ViveVIVE HEALTH LLCISA2026-10-09
00810226442627ViveVIVE HEALTH LLCISA2026-10-09