FDA.reportPublic FDA data

INDIBA DEEP CARE - REVERSO - Tip 160 pins

Primary DI
18434251002657
Brand
INDIBA DEEP CARE - REVERSO - Tip 160 pins
Company
INDIBA SA.
Model
ACC1016USA
Catalog number
REVERSO tip 160 pins
Device description
Radiofrequency devices. Accessory intended to spread the electric current evenly though a needle array into the target area to be treated in a functional manner.
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
18434251002657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1843425100265718434251002657

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
Dry Heat Sterilization

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
Sterilization required before use
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
08434251002667INDIBA DEEP CARE - REVERSO - Applicator handleACC1018USAREVERSO applicator handle2023-06-05
18434251002640INDIBA DEEP CARE - REVERSO - Tip 80 pinsACC1014USAREVERSO tip 80 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
00198506092930ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506092947ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506093234ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
04250418748346Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
04250418753722Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
08800020100481POTENZA TipJeisys Medical Inc.GEI2026-07-21
08800020101754POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101761POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101778POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020110541INTRAcel PremiumJeisys Medical Inc.GEI2026-07-21
00190776402143MillenniumAvalign Technologies, Inc.GEI2026-07-19
00198506092756ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16