FDA.reportPublic FDA data

REVERSO PRO SYSTEM

Primary DI
08434251004173
Brand
REVERSO PRO SYSTEM
Company
INDIBA SA.
Model
IDC0410
Catalog number
IDC0410USA
Device description
Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories.
Published
2025-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243139000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243139000Reverso Pro SystemIndiba S. A. U.2025-01-22GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08434251004173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08434251004173084342510041738434251004173

GMDN Terms#

Term, Definition table
TermDefinition
Intradermal radio-frequency ablation systemAn assembly of devices designed to apply radio-frequency (RF) energy to heat the dermal layer of the skin (e.g., the sebaceous glands) [invasive] for ablation (e.g., thermolysis) during an aesthetic procedure (e.g., acne treatment). It primarily consists of an electrically-powered control unit intended to produce and regulate the RF energy, and a connected monopolar RF applicator (probe) to deliver the RF energy to the skin; it may in addition include a bipolar (noninvasive) RF applicator.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
460060916
Device count
1
Serial number
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08434251003084INDIBA DEEP CARE - EVONYIDC0409IDC0409USA2025-02-06
08434251003640INDIBA ACTIV - ACTIV CT9ACT0309ACT0309BLKUSA2025-02-06
08434251000229INDIBA ACTIV - CT9ACT0309USAACT0309USA2019-02-06
08434251004791COMPACT LITEACT0507ACT0507USA2025-01-29
08434251004814COMPACT PLUSACT0508ACT0508USA2025-01-29
08434251004838COMPACT PROACT0509ACT0509USA2025-01-29
18434251002718INDIBA DEEP CARE - REVERSO - Tip 88 pinsACC1015REVERSO tip 88 pins2023-06-05
18434251002725INDIBA DEEP CARE - REVERSO - Tip 176 pinsACC1017REVERSO tip 176 pins2023-06-05
18434251002831INDIBA DEEP CARE - REVERSO - Tip 44 pinsACC1013REVERSO tip 44 pins2023-06-05
08434251002636INDIBA DEEP CARE - REVERSOIDC0400USAREVERSO2023-06-05
08434251002667INDIBA DEEP CARE - REVERSO - Applicator handleACC1018USAREVERSO applicator handle2023-06-05
18434251002640INDIBA DEEP CARE - REVERSO - Tip 80 pinsACC1014USAREVERSO tip 80 pins2023-06-05
18434251002657INDIBA DEEP CARE - REVERSO - Tip 160 pinsACC1016USAREVERSO tip 160 pins2023-06-05
08434251000915INDIBA ACTIV - AT7ACT0407USAAT72021-04-06
08434251000014INDIBA ACTIV - ACTIV 902ACT229ACT2292019-02-22
08434251000021INDIBA ACTIV - ACTIV 801ACT228ACT2282019-02-22
08434251000038INDIBA ACTIV - ACTIV 701ACT227ACT2272019-02-22
08434251000045INDIBA DEEP CARE - ELITEIDC0077IDC00772019-02-22
08434251000052INDIBA DEEP CARE - PREMIUMIDC0076IDC00762019-02-22
08434251000236INDIBA ACTIV - CT8ACT0308USAACT0308USA2019-02-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091292ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091308ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091377ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091384ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091391ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00860015792006NOVOCLEAR™ DeviceAventix Medical Inc.GEI2026-06-09
00860015792013AVENTIX® PFX SystemAventix Medical Inc.GEI2026-06-09
00685447020677RFP-100A™ RF Puncture GeneratorBOSTON SCIENTIFIC CORPORATIONGEI2026-06-08
08800042706159Artisential Monopolar SpatulaLIVSMEDGEI2026-06-05
00840319759042Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759059Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759066Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764089VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764133VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764140VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764157VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
00198506091261ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-03
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCGEI2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCGEI2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCGEI2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCGEI2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCGEI2026-06-03