FDA.reportPublic FDA data

DEKA SmartXide UltraSpeed 2

Primary DI
08057017760726
Brand
DEKA SmartXide UltraSpeed 2
Company
EL.EN. SPA
Model
M110F1
Device description
DEKA SmartXide UltraSpeed 2 is a 10,600 nm CO2 laser devices whit a maximum power of 40W.The laser source delivers the laser output through interchangeable laser handpieces.Handpiece activation is by footswitch.
Published
2023-04-27
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
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172362000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172362000DEKA SMARTXIDE TOUCHEl.En Electronic Engineering Spa2017-11-17GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057017760726PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057017760726080570177607268057017760726

GMDN Terms#

Term, Definition table
TermDefinition
Dental carbon dioxide laser systemA mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite carbon dioxide (active medium) to emit a beam of intense, coherent, monochromatic electromagnetic (EM) radiation for application in dental procedures, mainly to excise or vaporize tissue in the oral cavity. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch. It typically emits energy at a wavelength of 10,600 nm (far infrared) to tissues through a handpiece; it may be operated in continuous-wave or pulsed modes.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
436887608
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057017760108DEKA SYNCHRO REPLA:Y EXCELLIUM 3.4M104K1M104K12016-09-13
08057017760115DEKA SYNCHRO REPLA:Y EXCELLIUM HPM104L1M104L12016-09-13
08057017760122DEKA SYNCHRO REPLA:Y PREMIUM 1.4.2M104J1M104J12016-09-13
08057017760979EXIRAM126AC12026-02-16
08057017760962LUVOM117H12025-11-24
08057017760221DEKA Motus AXM112B1M112B12017-07-03
08057017760337DEKA Minisilk FTM081R1M081R12018-04-16
08057017760443Thermaeye PlusM081AN1M081AN12021-10-19
08057017760559ECHOLASER X4M095H1M095H12021-05-07
08057017760504ECHOLASER X4M095G1M095G12020-02-14
08057017760320ECHOLASER X4M095D1M095D12020-01-15
08057017760207SH1M077H3M077H32016-09-13
08057017760214DEKA HIRO 3.0M080K1M080K12016-09-13
08057017760498DEKA PHYSIQM120F1M120F12020-01-15
08057017760528DEKA SMARTPERIOM128A1M128A12022-04-05
08057017760856NIRVANAM117H12024-04-18
08057017760818ALLORA PROM126AC12024-02-14
08057017760535DEKA PHYSIQM120F1M120F12020-12-11
08057017760719DEKA SCULPTM116H1M116H12023-04-27
08057017760733DEKA TRUISTM117B1M117B12023-04-27

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