# K121481: Infini Radiofrequency System

- Pathway: 510(k) (Traditional)
- Applicant: Lutronic Corporation
- Decided: Jun 25, 2013 after 403 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: 10 generations back to K943450 (1995). 23 ancestors in all.
57 later devices descend from it; 9 cite it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082391: Primaeva Medical Renesis System, Primaeva Medical, Inc. (2009) Summary page 1.

## Most influential descendants
- 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
- K160469: AGNES (2017), 9 descendants of its own

## Indications for use
The INFINI Radiofrequency System is intended 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/K121481
Methodology: https://510kreport.com/methodology