# K153727: INTRAcel Premium Fractional RF Micro Needle (FRM) System

- Pathway: 510(k) (Traditional)
- Applicant: Jeisys Medical, Inc.
- Decided: Jul 21, 2016 after 206 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: 11 generations back to K943450 (1995). 24 ancestors in all.
27 later devices descend from it; 3 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121481: Infini Radiofrequency System, Lutronic Corporation (2013) Summary page 4.

## Most influential descendants
- K192545: Potenza (2020), 20 descendants of its own
- K201685: Potenza (2021), 9 descendants of its own
- K160469: AGNES (2017), 9 descendants of its own
- K192728: Agnes (2019), 6 descendants of its own
- K231216: Potenza (2024), 4 descendants of its own

## Indications for use
The INTRAcel Premium Fractional RF Micro Needle (FRM) System device is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

Source page: https://510kreport.com/device/K153727
Methodology: https://510kreport.com/methodology