# Premier North America, Inc.

- Location (FDA's records): Fort Lauderdale, FL
- FDA decisions: 6 (2018–2024): 6 510(k) clearances
- Product codes: OHS (3), OLP (1), GYB (1), NFO (1)
- 510(k) review time since 2016: median 53 days, against 98 for FDA's reviews in the same codes and years (4 of 4 faster)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 5 (1 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
- Omm Imports, Inc. D/B/A Zero Gravity: 1 (https://510kreport.com/company/omm-imports-d-b-a-zero-gravity)
- Home Skinovations, Ltd.: 1 (https://510kreport.com/company/home-skinovations)
- Omm Imports Inc Dba Zero Gravity: 1 (https://510kreport.com/company/omm-imports-dba-zero-gravity)
- Carol Cole Company: 1 (https://510kreport.com/company/carol-cole)
- Lyma Life, Ltd.: 1 (https://510kreport.com/company/lyma-life)
- Carol Cole Company Dba Nuface: 1 (https://510kreport.com/company/carol-cole-company-dba-nuface)

## Firms that cite its devices most
- Xplr, Ltd.: 2 (https://510kreport.com/company/xplr)
- Emoled, Srl: 1 (https://510kreport.com/company/emoled)
- Shenzhen Kaiyan Medical Equipment Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-kaiyan-medical-equipment)

## Its most-cited devices
- K232656: BLU TOTALE (Model: ENEOB852) (2023), cited by 2
- K181659: Avologi ENEO (2018), cited by 2
- K213841: ENEO TOTALE (Model: ENEOT947) (2022), cited by 1

## Recent decisions
- K233862: Nuna Lux (NUNL528) (Mar 1, 2024)
- K232656: BLU TOTALE (Model: ENEOB852) (Nov 14, 2023)
- K220735: Avologi Gel Primer (Model: Av25) (Sep 15, 2023)
- K214100: Luminice (Feb 24, 2022)
- K213841: ENEO TOTALE (Model: ENEOT947) (Jan 6, 2022)
- K181659: Avologi ENEO (Jul 26, 2018)

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