FDA.reportPublic FDA data

ThermiEyes

Primary DI
00817371020045
Brand
ThermiEyes
Company
Thermi
Model
ThermiEyes
Device description
ThermiEyes Radiofrequency Generator
Published
2016-09-23
Public version status
Update
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
K130689000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130689000SYMPHONY RF GENERATORThermigen, Inc.2013-11-15GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817371020045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817371020045008173710200458173710200450817371020045

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency ablation system generatorA mains electricity (AC-powered) device designed to generate radio-frequency (RF) electrical current used to create heat via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues (e.g., non-cardiac nerves, tumours, precancerous tissue); it may be intended for coagulation however it is not intended for electrosurgical cutting. The generator connects via a delivery cable to an electrosurgical ablation probe/catheter (not included) to transmit the RF electrical current to the operative site; it might additionally be intended to heat an electrode tip (electrocautery).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021008486
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817371020618ThermiRF+ThermiRF+2022-09-05
00817371020359ARVATIARVATI2021-09-22
00817371020014ThermiRFThermiRF2016-09-23
00817371020021ThermiSmoothThermiSmooth 202016-09-23
00817371020038ThermiVAThermiVa2016-09-23
00817371020052RFDE-VARFDE-VARFDE-VA-12016-09-23
00817371020069RF ElectrodeRFE-10-D2016-09-23
00817371020113Thermi Classic Radiofrequency Cannula S-505-B-202018-02-08
00817371020212Injectable RF ElectrodeV-10-10-18-B2017-09-20
00817371020229Injectable RF ElectrodeV-15-10-18-B2017-09-20
00817371020236Injectable RF ElectrodeV--20-10-16-B2017-09-20
00817371020243Injectable RF ElectrodeV-5-5-20-B2017-09-20
00817371020298Injectable RF ElectrodesV-Starter2017-09-20
00817371020274RF ElectrodeRFE-15-D2018-02-02

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