Duns Number:310762054
Device Description: The laser system is for dermatological indications for use. The laser light is delivered t The laser system is for dermatological indications for use. The laser light is delivered to the patient through an applicator either a scanning hand piece or a single spot hand piece (optional). The ADVATx Laser System consists of a laser cabinet which houses the laser module, the user interface which allows the user to control the system and the laser delivery system. ADVATx does only come in one model. The laser does not use any consumables (besides standard power/electricity), and no accessories are offered. The ADVATx laser system is a Nd:YAG laser delivering 589nm Q-switched pulsed light and 1319nm continuous wave light. This laser has been developed specifically for dermatological (skin) treatments performed by healthcare professionals e.g. doctors.
Catalog Number
684
Brand Name
ADVATx
Version/Model Number
1.0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132976,K132976
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
fa3c3b0e-01f7-4207-81cc-e8e9d3598d49
Public Version Date
August 24, 2021
Public Version Number
4
DI Record Publish Date
September 18, 2016
Package DI Number
05700002052216
Quantity per Package
1
Contains DI Package
05700002052209
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
colli