Advalight ApS

Address:Industriparken 22 A,Ballerup Hovedstaden,DK

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Powered Laser Surgical Instrument (GEX) (1)

Premarket Exempt

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ADVATx - 05700002052209 Catalog Number : 684

Device Description : The laser system is for dermatological indications for use. The laser light is d 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.

Device Class :

Duns Number: 310762054

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

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