FDA.reportPublic FDA data

ZIONIC AESTHETIC

Primary DI
08436601290793
Brand
ZIONIC AESTHETIC
Company
TERMOSALUD SL
Model
DEEP ACTION MAX 19MM
Catalog number
A464
Published
2024-12-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PBXMassager, Vacuum, Radio Frequency Induced Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBXMassager, Vacuum, Radio Frequency Induced HeatGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230659000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230659000Zionic AestheticTermosalud2023-06-08PBX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08436601290793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436601290793084366012907938436601290793

GMDN Terms#

Term, Definition table
TermDefinition
Medium-wave diathermy treatment systemAn assembly of devices designed to produce a therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency (RF) bands of 0.5 megahertz (MHz) to 1 MHz. It typically consists of an electric generator and two electrodes (active and return) intended to be held on/near the patient. The system is commonly used in outpatient, rehabilitation, traumatology, and sports centre settings to treat pain, muscle spasms, and joint contractures; it is not used for surgery or to treat malignancies.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
470725128
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08436601290519ZIONIC AESTHETICZIONIC AESTHETIC M98AE2024-12-13
08436601290526ZIONIC AESTHETICZIONIC AESTHETIC HPA463AE2024-12-13
08436601290809ZIONIC AESTHETICDEEP ACTION 30MMA4652024-12-13
08436601291332TERMOSALUDNEUTRAL RETURN PLATE 34DA52882024-12-13
00850060304002Deep2DEEP2M992024-10-21
00850060304019Deep2 SUCTION NOZZLE CUPPING DEEP2AR000084992024-10-21
00850060304026Deep2CLEANSING CUPAR00008619 2024-10-21
00850060304033Deep2VACUUM CUPPING CUPAR00008618 2024-10-21
00850060304040Deep2BOX 20 UNITS BLUNT TIP AR00008763 2024-10-21
00850060304057Deep2BOX 20 UNITS MEDIUM GRIT AR000083232024-10-21
00850060304064Deep2BOX 20 UNITS ABRASIVE DIAMOND TIP FINE GRITAR00008317 2024-10-21
00850060304088Deep2GLIT - HP HYDRODERMABRASION DEEP2 A4892024-10-21
00850060304095Deep2CALYX - CUPPING HP DEEP2 A4882024-10-21
00850060304101Deep2LUX - CHROMOTHERAPY HP DEEP2 A4902024-10-21
00850060304071Deep2BOX 20 UNITS ABRASIVE DIAMOND TIP COARSE GRIT AR000083242024-10-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974223650141WinForthShenzhen Leaflife Technology Co., Ltd.PBX2026-04-22
07290016746402V-FR HandpieceVIORA LTDPBX2026-04-19
07290016746501V-FR TipVIORA LTDPBX2026-04-19
00810060832851Venus NovaVenus Concept Inc.PBX2026-04-15
00850055552494BellaTform ApplicatorInbella Medical IncPBX2026-04-02
00850055552180BellaPlus90 ApplicatorInbella Medical IncPBX2026-03-30
00850055552715i-BellaForma ApplicatorInbella Medical IncPBX2026-03-30
00850055552005BellaBodyFX ApplicatorInbella Medical IncPBX2026-03-26
00850055552036BellaForma ApplicatorInbella Medical IncPBX2026-03-26
00850055552043BellaPlus ApplicatorInbella Medical IncPBX2026-03-26
00850055552067BellaMiniFX ApplicatorInbella Medical IncPBX2026-03-26
00850055552470InBellaBody SystemInbella Medical IncPBX2026-03-25
00850055552555InBellaMax SystemInbella Medical IncPBX2026-03-25
08056182720634SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721143SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721167SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721174SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721181SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721198SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721204SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721211SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721327SUPERCHARGE HYDRA FASCIA ELECTRODES UNIBELL SRLPBX2026-03-16
08800092098013D20-RF0BDaeyang Medical Co., Ltd.PBX2026-03-10
04053915986880Tecarpuls IIZimmer MedizinSysteme GmbHPBX2026-02-12
07290016746563V-IPL Optic set Full 6 filtersVIORA LTDPBX2025-12-22
07290016814569PRO MAX, System, 110VENDYMED MEDICAL LTDPBX2025-11-17
08034108513270ONDA PRODEKA M.E.L.A. SRLPBX2025-11-17
08034108513263body ESTIQDEKA M.E.L.A. SRLPBX2025-09-26
07290016746785V-FC Pro FullVIORA LTDPBX2025-09-01
07290016746808V-FC Pro TipVIORA LTDPBX2025-09-01