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AdvaLight APS

Matched from indexed company URL: ADVALIGHT APS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30106832263010683226AdvaLight APS1N2026-01-01Industriparken 22 A Ballerup Hovedstaden DK DK-2750

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05700002052209ADVATx - 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.+4546965412tma@advalight.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1713821776554106K132976ADVATXGEX2014-04-17
1713821777063280K120573MEDART 620GEX2012-06-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX22014-04-17

PMN#

GUDID#

ADVATx - 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.

Advalight ApS

2016-09-18