# Primaeva Medical, Inc.

- Location (FDA's records): Fremont, CA
- FDA decisions: 3 (2007–2009): 3 510(k) clearances
- Product codes: GEI (3)
- Predicates its devices cite: 7 (3 its own); citations of its devices by later devices: 8 (3 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
- Thermage, Inc.: 2 (https://510kreport.com/company/thermage)
- Arthrocare Corp.: 1 (https://510kreport.com/company/arthrocare)
- Radionics, Inc.: 1 (https://510kreport.com/company/radionics)

## Firms that cite its devices most
- Syneron Candela Corporation: 2 (https://510kreport.com/company/syneron-candela)
- Endymed Medical, Ltd.: 1 (https://510kreport.com/company/endymed-medical)
- Newlands Clinical Trials, Ltd.: 1 (https://510kreport.com/company/newlands-clinical-trials)
- Lutronic Corporation: 1 (https://510kreport.com/company/lutronic)

## Its most-cited devices
- K080145: Primaeva Medical System (2008), cited by 4
- K082391: Primaeva Medical Renesis System (2009), cited by 2
- K072261: Finesse System (2007), cited by 2

## Recent decisions
- K082391: Primaeva Medical Renesis System (Sep 1, 2009)
- K080145: Primaeva Medical System (Feb 28, 2008)
- K072261: Finesse System (Dec 26, 2007)

Source page: https://510kreport.com/company/primaeva-medical