FDA.reportPublic FDA data

LipoSense 150mm & 260mm Mercedes Cannula (3mm) with Temp Sensor

Primary DI
17290110123069
Brand
LipoSense 150mm & 260mm Mercedes Cannula (3mm) with Temp Sensor
Company
ALMA LASERS LTD.
Model
1
Catalog number
AALS23082301
Published
2023-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K212073000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212073000Alma Diode Tabletop LaserAlma Lasers , Ltd.2022-07-14GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290110123069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729011012306917290110123069

GMDN Terms#

Term, Definition table
TermDefinition
Liposuction system cannula, reusableA rigid tube that functions as a component of a lipectomy suction system and designed specifically for percutaneous insertion into body fat deposits for the aspiration of fat during liposuction/lipoplasty. The device may also be used to infiltrate the operative site with a solution during the procedure, which is then aspirated. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
532283264
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

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