NEAUVIA NORTH AMERICA, INC.

Address:8480 Honeycutt Rd,Raleigh,NC,27615,US

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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

Electrosurgical, Cutting & Coagulation & Accessories (GEI) (6) Brush, Dermabrasion, Powered (GFE) (3) Disinfectant, Medical Devices (LRJ) (1)

Premarket Exempt

No Yes

Clear

Plasma IQ System - 00850017374003 Catalog Number : 100-1200

Device Description : PLASMA IQ utilizes a treatment method called plasma sublimation, which causes co PLASMA IQ utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of a targeted micro beam of plasma energy. The arc between the electrode tip and the skin is created by a radio frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A straight active electrode made of 316L stainless steel is available with the system. The handheld device is cordless and is charged in a docking/charging station prior to use.

Device Class : 2

Duns Number: 117030786

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Plasma IQ Electrode Straight (1 piece) - 00850017374010 Catalog Number : 200-1201

Device Description : 1 straight electrode for use with Plasma IQ

Device Class : 2

Duns Number: 117030786

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Plasma IQ Electrode Straight (10 piece) - 00850017374027 Catalog Number : 200-1202

Device Description : 10 piece Straight electrode package for use with Plasma IQ

Device Class : 2

Duns Number: 117030786

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Plasma IQ Docking Station - 00850017374034 Catalog Number : 300-1201

Device Description : Charging station for use with Plasma IQ

Device Class : 2

Duns Number: 117030786

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Plasma IQ Handpiece - 00850017374041 Catalog Number : 300-1202

Device Description : Individual handpiece for the Plasma IQ System

Device Class : 2

Duns Number: 117030786

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Zaffiro IR Treatment Applicator - 00850017374065 Catalog Number : 300-1104

Device Description : Applicator to perform a non-invasive, thermo-lifting with the Zaffiro System

Device Class : 1

Duns Number: 117030786

Premarket Exempt : Yes

Product Code : GFE

Prescription Use : No

Device Count : 1

Zaffiro WP Treatment Applicator - 00850017374072 Catalog Number : 300-1102

Device Description : Treatment Applicator designed to deep clean, resurface and nourish skin with the Treatment Applicator designed to deep clean, resurface and nourish skin with the Zaffiro System.

Device Class : 1

Duns Number: 117030786

Premarket Exempt : Yes

Product Code : GFE

Prescription Use : No

Device Count : 1

Zaffiro System - 00850017374089 Catalog Number : 100-1100

Device Description : Zaffiro is a state-of-the-art instrument designed to deep clean, resurface and n Zaffiro is a state-of-the-art instrument designed to deep clean, resurface and nourish skin and perform a non-invasive, thermo-lifting.

Device Class : 1

Duns Number: 117030786

Premarket Exempt : Yes

Product Code : GFE

Prescription Use : No

Device Count : 1

NPure System - 00850017374096 Catalog Number :

Device Class : 1

Duns Number: 117030786

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Plasma IQ Electrode Curved (1 piece) - 00850017374102 Catalog Number : 200-1203

Device Description : 1 curved electrode for used with Plasma IQ

Device Class : 2

Duns Number: 117030786

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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