ADVATx - The laser system is for dermatological - Advalight ApS

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.

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More Product Details

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

Product Characteristics

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"

-

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 Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

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

Additional Identifiers

Package DI Number

05700002052216

Quantity per Package

1

Contains DI Package

05700002052209

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

colli