FDA.report

EXELO2 CO2 Laser System

Primary DI
17290110121164
Brand
EXELO2 CO2 Laser System
Company
ALMA LASERS LTD.
Model
1
Catalog number
QTL-EXELO2-11071201
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ONGPowered Laser Surgical Instrument With Microbeam\Fractional Output

Product Code Classifications

CodeDeviceSpecialtyClass
ONGPowered Laser Surgical Instrument With MicrobeamFractional OutputGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
17290110121164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1729011012116417290110121164

GMDN Terms

TermDefinition
Ultrasonic hyperthermia systemAn assembly of devices designed to produce and control the delivery of high heat (i.e., temperatures greater than 43? Celsius) to the body using ultrasonic energy for the intracorporeal or extracorporeal treatment of malignant or benign tumours, or other disease conditions. It is typically computer-controlled and is capable of producing whole-body or localized heating within tissues or organs. Energy delivered to the patient is from either an externally-mounted transducer or a transducer-containing catheter or probe used topically or inserted endoscopically or surgically. Unlike an ultrasound diathermy system, an ultrasound hyperthermia system is not used in physiotherapy applications.

Sterilization Methods

Method

Regulatory Flags

DUNS number
532283264
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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