FDA.reportPublic FDA data

Echolaser Smart Interface (ESI)

Primary DI
08052286590173
Brand
Echolaser Smart Interface (ESI)
Company
ELESTA SPA
Model
EI KT0 0005 521
Device description
Echolaser Smart Interface (ESI) and its accessories
Published
2021-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OUGMedical Device Data System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08052286590173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052286590173080522865901738052286590173

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound-guided laser thermal therapy needle guide positioning systemAn assembly of noninvasive devices intended for use during soft-tissue lesion treatment by ultrasound-guided laser thermal therapy, to provide software-based simulation of tissue thermal damage for assisting the manual positioning of percutaneous needles through which laser applicators (not included) are introduced. It consists of an electrically-powered interface/display and needle guides for attachment to a body-surface ultrasound (US) imaging probe/transducer; the system overlays real-time US images [from a separate US system] with the predicted laser thermal effect, estimated via input parameters (e.g., angle of attachment between needle guide and US probe/transducer, treatment dose).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
895683282
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08052286590500LASER THERMAL THERAPY KIT S EEI KT0 0011 0012026-03-24
08052286590517LASER THERMAL THERAPY KIT L EEI KT0 0011 0022026-03-24
08052286590210Laser Thermal Therapy Kit S EEI KT0 0011 0012023-11-06
08052286590227Laser Thermal Therapy Kit L EEI KT0 0011 0022023-11-06
08052286590012Elesta - IntroducerCH2120. 6EC2019-04-23
08052286590135INTRODUCER EI AG2 0020 6202021-06-19
08052286590142INTRODUCER EI AG2 0020 6402021-06-19
08052286590005Elesta - IntroducerCH2111. 6EC2019-04-23
08052286590159INTRODUCER EI AG2 0020 6202021-06-19
08052286590166INTRODUCER EI AG2 0020 6402021-06-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826921209PENTAX MedicalPENTAX MEDICAL CORPORATIONOUG2026-08-25
00850015699160Canary Flight PlanCanary Medical USA LLCOUG2026-08-07
00850015699177Canary Recovery CurveCanary Medical USA LLCOUG2026-08-07
04048675544227Connectivity Converter CC300Drägerwerk AG & Co. KGaAOUG2026-07-17
04260658860258myoncareONCARE GmbHOUG2026-07-17
00840241600443Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-07-16
00884400004871GoClinicMonitored Therapeutics, Inc.OUG2026-07-16
00884400085481GoMobileMonitored Therapeutics, Inc.OUG2026-07-16
04035479194192PatientApp 2.10.0BIOTRONIK SE & Co. KGOUG2026-07-16
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
04048675558552Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558569Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558576Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675663997Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
07613327632811MaistroSTRYKER CORPORATIONOUG2025-10-10
00763000191887N/AMEDTRONIC, INC.OUG2025-09-05
00763000292102N/AMEDTRONIC, INC.OUG2025-09-05
00841492105671ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105688ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105695ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105701ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105718ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105725ResponderRAULAND-BORG CORPORATIONOUG2025-06-24