FDA.reportPublic FDA data

INDIBA DEEP CARE - REVERSO - Applicator handle

Primary DI
08434251002667
Brand
INDIBA DEEP CARE - REVERSO - Applicator handle
Company
INDIBA SA.
Model
ACC1018USA
Catalog number
REVERSO applicator handle
Device description
Radiofrequency devices. Accessory intended to transmit the electric current generated by the RF generator to the tips.
Published
2023-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
K212107000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212107000ReversoIntelis Instruments , Ltd.2021-11-10GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08434251002667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08434251002667084342510026678434251002667

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
DM exempt
true
Combination product
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08434251004173REVERSO PRO SYSTEMIDC0410IDC0410USA2025-07-31
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
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
00197998302718Solventum™Solventum US LLCGEI2026-09-25
00724995269586Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269951Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269968Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00190776432300MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432317MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432324MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432430MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432447MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432454MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776431457MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432041MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432195MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432201MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776431181MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431198MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431204MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431211MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431228MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431235MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431242MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431259MillenniumAvalign Technologies, Inc.GEI2026-09-21
10840113236852BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236890BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236937BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237040BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237064BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237101BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237118BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237132BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21