neauvia-us.comLaserME
Neauvia North America
NEAUVIA NORTH AMERICA, INC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015433394 | 3015433394 | NEAUVIA NORTH AMERICA, INC | 1 | Y | 2026-01-01 | 8480 Honeycutt Rd Raleigh NC US 27615 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850017374225 | Zaffiro IR Treatment Body Applicator - Bigger applicator to perform a non-invasive, thermo-lifting on the body with the Zaffiro System | 984-777-5296 | joy@neauvia-us.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 234845 | 1584085215 | K230077 | LaserME | GEX | 2023-07-17 |
| 234845 | 1564165348 | K223222 | Plasma IQ | GEI | 2023-01-17 |
| 234845 | 1520273688 | K213261 | EpilME | GEX | 2022-06-02 |
| 234845 | 1596533589 | K202780 | Sectum | PBX | 2021-07-30 |
| 234845 | 1311321624 | K192813 | Plasma IQ | GEI | 2020-03-06 |
| 234845 | 1107877777 |
Product Codes Associated With Registrations#
PMN#
GUDID#
Zaffiro IR Treatment Body Applicator - Bigger applicator to perform a non-invasive, thermo-lifting on the body with the Zaffiro System
2026-02-11
EpilMe Applicator - Handpiece applicator for EpilMe System
2022-10-03
EpilMe System - Laser EpilME with EpilME applictor is indicated for use in surgical and aesthetic applications in the medical specialtiesof general and plastic surgery, and dermatology.
2022-10-03
LaserMe - The LaserMe is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The LaserMe is further indicated for treatment of benign pigmented lesions, such as, but not limited to lentigines (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.
2023-08-15
Sectum Cable Precise (Face) Applicator - 300-1310
2021-09-27
Sectum Cable Body Applicator - 300-1308
2021-09-27
Sectum Foot Switch - Foot switch for the Sectum System
2021-09-27
Sectum Body Applicator - 300-1301
2021-09-27
Sectum Precise (Face) Applicator - 300-1302
2021-09-27
Sectum System - 100-1301
2021-09-27
Plasma IQ Electrode Curved (10 piece) - 10 piece curved electrode package for use with Plasma IQ
2020-09-14
Plasma IQ Electrode Curved (1 piece) - 1 curved electrode for used with Plasma IQ
2020-09-14
Plasma IQ Handpiece - Individual handpiece for the Plasma IQ System
2020-09-14
Plasma IQ Docking Station - Charging station for use with Plasma IQ
2020-09-14
Plasma IQ Electrode Straight (10 piece) - 10 piece Straight electrode package for use with Plasma IQ
2020-09-14
Plasma IQ Electrode Straight (1 piece) - 1 straight electrode for use with Plasma IQ
2020-09-14
Plasma IQ System - 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.
2020-09-14
NPure System - 100-1500
2021-09-24
Zaffiro System - Zaffiro is a state-of-the-art instrument designed to deep clean, resurface and nourish skin and perform a non-invasive, thermo-lifting.
2020-09-14
Zaffiro WP Treatment Applicator - Treatment Applicator designed to deep clean, resurface and nourish skin with the Zaffiro System.
2020-09-14
Zaffiro IR Treatment Applicator - Applicator to perform a non-invasive, thermo-lifting with the Zaffiro System
2020-09-14