NEAUVIA NORTH AMERICA, INC.

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

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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

Electrosurgical, Cutting & Coagulation & Accessories (GEI) (7) Massager, Vacuum, Radio Frequency Induced Heat (PBX) (6) Powered Laser Surgical Instrument (GEX) (2)

Premarket Exempt

No Yes

Clear

Plasma IQ Electrode Curved (10 piece) - 00850017374119 Catalog Number : 200-1204

Device Description : 10 piece curved 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

Sectum System - 00850017374126 Catalog Number :

Device Class : 2

Duns Number: 117030786

Premarket Exempt : No

Product Code : GEI, PBX

Prescription Use : No

Device Count : 1

Sectum Precise (Face) Applicator - 00850017374133 Catalog Number :

Device Class : 2

Duns Number: 117030786

Premarket Exempt : No

Product Code : GEI, PBX

Prescription Use : No

Device Count : 1

Sectum Body Applicator - 00850017374140 Catalog Number :

Device Class : 2

Duns Number: 117030786

Premarket Exempt : No

Product Code : GEI, PBX

Prescription Use : No

Device Count : 1

Sectum Foot Switch - 00850017374157 Catalog Number :

Device Description : Foot switch for the Sectum System

Device Class : 2

Duns Number: 117030786

Premarket Exempt : No

Product Code : GEI, PBX

Prescription Use : No

Device Count : 1

Sectum Cable Body Applicator - 00850017374164 Catalog Number :

Device Class : 2

Duns Number: 117030786

Premarket Exempt : No

Product Code : GEI, PBX

Prescription Use : No

Device Count : 1

Sectum Cable Precise (Face) Applicator - 00850017374171 Catalog Number :

Device Class : 2

Duns Number: 117030786

Premarket Exempt : No

Product Code : GEI, PBX

Prescription Use : No

Device Count : 1

EpilMe System - 00850017374201 Catalog Number :

Device Description : Laser EpilME with EpilME applictor is indicated for use in surgical and aestheti Laser EpilME with EpilME applictor is indicated for use in surgical and aesthetic applications in the medical specialtiesof general and plastic surgery, and dermatology.

Device Class : 2

Duns Number: 117030786

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

EpilMe Applicator - 00850017374218 Catalog Number :

Device Description : Handpiece applicator for EpilMe System

Device Class : 2

Duns Number: 117030786

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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