# Neauvia North America

- Location (FDA's records): Raliegh, NC
- FDA decisions: 6 (2020–2023): 6 510(k) clearances
- Names in FDA's records: Neauvia North America (3); Neauvia North America, Inc. (3)
- Product codes: GEI (3), GEX (2), PBX (1)
- 510(k) review time since 2016: median 173 days, against 126 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 8 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Palomar Medical Products, Inc.: 1 (https://510kreport.com/company/palomar-medical-products)
- Lumenis, Inc.: 1 (https://510kreport.com/company/lumenis)
- Venus Concept, Ltd.: 1 (https://510kreport.com/company/venus-concept)
- Bovie Medical Corporation: 1 (https://510kreport.com/company/bovie-medical)

## Firms that cite its devices most
- Shenzhen Leaflife Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-leaflife-technology)
- Cartessa Aesthetics: 1 (https://510kreport.com/company/cartessa-aesthetics)
- Hironic Co., Ltd.: 1 (https://510kreport.com/company/hironic)
- Gmv S.R.L.: 1 (https://510kreport.com/company/gmv)
- Reveal Lasers, Ltd.: 1 (https://510kreport.com/company/reveal-lasers)
- Bh Group Us, LLC: 1 (https://510kreport.com/company/bh-group-us)

## Its most-cited devices
- K192813: Plasma IQ (2020), cited by 3
- K212329: Plasma IQ (2021), cited by 2
- K230077: LaserME (2023), cited by 1
- K223222: Plasma IQ (2023), cited by 1
- K202780: Sectum (2021), cited by 1

## Recent decisions
- K230077: LaserME (Jul 17, 2023)
- K223222: Plasma IQ (Jan 17, 2023)
- K213261: EpilME (Jun 2, 2022)
- K212329: Plasma IQ (Dec 9, 2021)
- K202780: Sectum (Jul 30, 2021)
- K192813: Plasma IQ (Mar 6, 2020)

Source page: https://510kreport.com/company/neauvia-north-america