AP MEDESTHETICS, INC.

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Filters

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

Electrode, Needle (GXZ) (2)

Premarket Exempt

Clear

Bristle needles - 18657300002204 Catalog Number :

Device Description : The single piece device is a plastic handle fused to a stainless-steel needle, i The single piece device is a plastic handle fused to a stainless-steel needle, insulated to the tip. The other end of the plastic handle is fused to a flexible lead wire and a “touch-proof” safety connector. The device is used to transfer RF energy from the VeinGogh generator to the spider vein.

Device Class : 2

Duns Number: 056296605

Premarket Exempt : No

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

Bristle needles - 28657300002201 Catalog Number :