# K082391: Primaeva Medical Renesis System

- Pathway: 510(k) (Traditional)
- Applicant: Primaeva Medical, Inc.
- Decided: Sep 1, 2009 after 378 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: 9 generations back to K943450 (1995). 22 ancestors in all.
59 later devices descend from it; 2 cite it directly.
0 of 82 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.
- K080145: Primaeva Medical System, Primaeva Medical, Inc. (2008) Summary page 1.

## Most influential descendants
- K121481: Infini Radiofrequency System (2013), 57 descendants of its own
- K153727: INTRAcel Premium Fractional RF Micro Needle (FRM) System (2016), 27 descendants of its own
- K192545: Potenza (2020), 20 descendants of its own
- K201685: Potenza (2021), 9 descendants of its own
- K180359: BTL-FR2000 (2018), 9 descendants of its own

## Indications for use
The Primaeva Medical Miratone System is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.

Source page: https://510kreport.com/device/K082391
Methodology: https://510kreport.com/methodology