FDA.reportPublic FDA data

DEKA Minisilk FT

Primary DI
08057017760337
Brand
DEKA Minisilk FT
Company
EL.EN. SPA
Model
M081R1
Catalog number
M081R1
Device description
The Minisilk-FT is a pulsed light system having a Xenon flashlamp located in the handpieces. It is a light source emitting in the wavelength range 500-1200nm. Emission activation is by footswitch. Overall weight of the system is 16kg, and the size is 22x37x45cm (HxWxD).Electrical requirement is: 115 VAC, 10A, 50-60 Hz, single phase.
Published
2018-04-16
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
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal EffectGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082040000MINISILK FTEl.En Electronic Engineering Spa2009-08-27ONF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057017760337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057017760337080570177603378057017760337

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin/body contouring systemAn assembly of devices intended to use a combination of noninvasive energies and methods to locally reduce the subcutaneous fat layer, cellulite manifestation, and loose or wrinkled skin appearance. It consists of an electrically-powered control unit/generator to produce two or more energy modalities [e.g., radio-frequency, thermal/cryogenic (for cryolipolysis), high intensity focused ultrasound (HIFU), infrared light], and body-surface applicators to apply the treatment to the target area (e.g., chin, hips, abdomen, thighs); some types are additionally capable of applying vacuum.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature20 Degrees Celsius30 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

Regulatory Flags#

DUNS number
436887608
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057017760979EXIRAM126AC12026-02-16
08057017760962LUVOM117H12025-11-24
08057017760221DEKA Motus AXM112B1M112B12017-07-03
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
08057017760726DEKA SmartXide UltraSpeed 2M110F12023-04-27
08057017760535DEKA PHYSIQM120F1M120F12020-12-11
08057017760719DEKA SCULPTM116H1M116H12023-04-27
08057017760733DEKA TRUISTM117B1M117B12023-04-27
08057017760665DEKA HELIXM133A1M133A12023-03-21
08057017760108DEKA SYNCHRO REPLA:Y EXCELLIUM 3.4M104K1M104K12016-09-13
08057017760115DEKA SYNCHRO REPLA:Y EXCELLIUM HPM104L1M104L12016-09-13

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