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
00190776429140MillenniumAvalign Technologies, Inc.GEI2026-09-04
00840113233281BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233304BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233328BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233342BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233366BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233380BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233403BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233427BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233441BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233465BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233489BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233502BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233526BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237326BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237340BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237593BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237623BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237661BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237692BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00190776428006MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428037MillenniumAvalign Technologies, Inc.GEI2026-08-27
B4193533010Maxtown MedicalModern Surgical Instruments LLCGEI2026-08-27
ESUMARS980010SutterSutter Medizintechnik GmbHGEI2026-08-27
00190776427436MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427542MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427573MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427672MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427689MillenniumAvalign Technologies, Inc.GEI2026-08-26
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDGEI2026-08-26