# K183284: INTRAcel RF Microneedle System

- Pathway: 510(k) (Traditional)
- Applicant: Jeisys Medical, Inc.
- Decided: Jan 15, 2020 after 415 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: 12 generations back to K943450 (1995). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153727: INTRAcel Premium Fractional RF Micro Needle (FRM) System, Jeisys Medical, Inc. (2016) Summary page 4.

## Indications for use
INTRAcel RF Microneedle System is indicated for use in dermatological and general surgical procedures for electrocoagulation, hemostasis and the percutaneous fractional treatment of the skin in monopolar and bipolar mode.

Source page: https://510kreport.com/device/K183284
Methodology: https://510kreport.com/methodology