FDA.reportPublic FDA data

RF Generator

Primary DI
00810026181597
Brand
RF Generator
Company
SONIQUENCE, LLC
Model
IEC6-IENSU120
Catalog number
IEC6-IENSU120
Device description
RF Generator
Published
2020-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K183611000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183611000Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC2019-05-22GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810026181597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810026181597008100261815978100261815970810026181597

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical systemAn assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for inert gas-enhanced electrosurgery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117308190
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810026183782SP-TipSST-MWSST-MW2025-07-18
00810026183652SP-TipSST-T10SST-T102023-10-06
00810026183690Soni-CervSST-SB3SST-SB32023-10-06
00810026183669SP-TipSST-T10SST-T102023-10-06
00810026183706Soni-CervSST-SB3SST-SB32023-10-06
00810026183775Bleph kitSBK-01SBK-012023-10-06
00810026180248Blepharoplasty kitSBK-01SBK-012022-04-11
00810026180972Reusable HandpieceSIEC-3FHPB/NSSIEC-3FHPB/NS2022-12-30
00810026181535RF GeneratorIEC6-SESP120IEC6-SESP1202020-05-19
00810026181542RF GeneratorIEC6-IESP170IEC6-IESP1702020-05-19
00810026181559RF GeneratorIEC6-IENSP170IEC6-IENSP1702020-05-19
00810026181566RF GeneratorIEC6-SESP170IEC6-SESP1702020-05-19
00810026181573RF GeneratorIEC6-SENSP170IEC6-SENSP1702020-05-19
00810026181580RF GeneratorIEC6-IESU120IEC6-IESU1202020-05-19
00810026181603RF GeneratorIEC6-SENSU120IEC6-SENSU1202020-05-19
00810026181610RF GeneratorIEC6-SESU120IEC6-SESU1202020-05-19
00810026181627RF GeneratorIEC6-IESU170IEC6-IESU1702020-05-19
00810026181634RF GeneratorIEC6-IENSU170IEC6-IENSU1702020-05-19
00810026181641RF GeneratorIEC6-SESU170IEC6-SESU1702020-05-19
00810026181658RF GeneratorIEC6-SENSU170IEC6-SENSU1702020-05-19

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