FDA.reportPublic FDA data

Accent Vshape UniBody Handpiece

Primary DI
17290110120167
Brand
Accent Vshape UniBody Handpiece
Company
ALMA LASERS LTD.
Model
1
Catalog number
AAUN27091204
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072699000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072699000ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MODELS: ACCENT, ACCENT XLAlma Lasers , Ltd.2007-10-05GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290110120167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729011012016717290110120167

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
532283264
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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07290110122317Accent Prime System 120V For Inc.1AAAP07042201BA00012022-11-22
07290110122324Accent Prime UltraSpeed Applicator for Inc.1AAAP070422112022-11-22
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Primary DI, Brand, Company table
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