# K080145: Primaeva Medical System

- Pathway: 510(k) (Special)
- Applicant: Primaeva Medical, Inc.
- Decided: Feb 28, 2008 after 37 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K943450 (1995). 21 ancestors in all.
99 later devices descend from it; 4 cite it directly.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072261: Finesse System, Primaeva Medical, Inc. (2007) Summary page 1.

## Most influential descendants
- K082391: Primaeva Medical Renesis System (2009), 59 descendants of its own
- K130501: Intensif (2014), 57 descendants of its own
- K121481: Infini Radiofrequency System (2013), 57 descendants of its own
- K180189: InMode System with Fractora3D/3D-90 Applicators (2018), 38 descendants of its own
- K153727: INTRAcel Premium Fractional RF Micro Needle (FRM) System (2016), 27 descendants of its own

## Indications for use
The Primaeva Medical Finesse System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

Source page: https://510kreport.com/device/K080145
Methodology: https://510kreport.com/methodology