FDA.reportPublic FDA data

DEKA LIPOAI

Primary DI
08057017760580
Brand
DEKA LIPOAI
Company
EL.EN. SPA
Model
M131A1
Catalog number
M131A1
Device description
The LipoAI is medical laser equipped with a short pulse 1444 nm Nd:YAG laser source. The device delivers the laser energy through a 600 um optical fiber. The fiber is protected by a small stainless-steel cannula (max. 1.4mm) and is inserted in the tissue through a small aperture in the skin.
Published
2022-04-05
Public version status
New
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
K212270000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212270000DEKA LipoAIEl.En Electronic Engineering Spa2021-10-21GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057017760580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057017760580080570177605808057017760580

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for general surgery and/or multiple specialized surgical applications (non-dedicated), which may include treatment of vascular diseases. It vaporizes/ablates soft tissue with moderate haemostasis, little charring, and a thin zone of necrosis. It includes a light source, delivery/positioning device(s), and controls/foot-switch and emits a midinfrared wavelength. It does not include frequency doubling technology.

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
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
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

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Primary DI, Brand, Company table
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08800291820859PICOPLUSCynosure Lutronic Technology CorporationGEX2026-06-22
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