FDA.reportPublic FDA data

BC Large Applicator

Primary DI
07290016746266
Brand
BC Large Applicator
Company
VIORA LTD
Model
VTL45920
Catalog number
VTL45920
Device description
BC Large 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
ISAMassager, Therapeutic, Electric
PBXMassager, Vacuum, Radio Frequency Induced Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1
PBXMassager, Vacuum, Radio Frequency Induced HeatGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150035000
K152611000
K162363000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150035000V10 systemViora , Ltd.2015-05-01PBX
K152611000V20 systemViora , Ltd.2016-02-19GEX
K162363000V30 system, V-Form Handpiece BC Medium applicatorViora , Ltd.2016-11-18GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016746266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016746266072900167462667290016746266

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810140063229Renpho RejuvenJoicom CorporationISA2026-10-20
08809932290075NeoSculpt PlusS&M Medical Inc.PBX2026-10-20
B108499AP1MRA1MUS00Large applicatorBTL INDUSTRIES LIMITEDPBX2026-10-20
B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDPBX2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDPBX2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDPBX2026-10-20
B108890APMMUS00EMFACE controllerBTL INDUSTRIES LIMITEDPBX2026-10-12
00810226442610ViveVIVE HEALTH LLCISA2026-10-09
00810226442627ViveVIVE HEALTH LLCISA2026-10-09
00810226442634ViveVIVE HEALTH LLCISA2026-10-09
00810226442641ViveVIVE HEALTH LLCISA2026-10-09
08809932290082NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290099NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290105NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290112NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290129NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290136NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290143NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
00872320007218SveltivaCAO GROUP, INC.PBX2026-10-01
00850018480888Primo PassiPrimo Passi LLCISA2026-09-21
00860014139918QUASONIQ+Global Good, Corp.ISA2026-09-21
08032625821120GLOBUSDOMINO SRLPBX2026-09-19
06977444420005Shuhai JingweiShuhai Jingwei (Shenzhen) Information Technology Co., Ltd.ISA2026-09-04
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDPBX2026-08-26
08800250281332QuadtheraECO DM LAB Co., Ltd.ISA2026-08-21
00817915020296Etekcity Smart Fitness ScaleVesync (US) CorporationISA2026-08-14
088095244976843H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244976913H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977073H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977143H Smart Massage Bed3H, Co., LtdISA2026-07-29