# K142833: INTRAGen

- Pathway: 510(k) (Traditional)
- Applicant: Jeisys Medical, Inc.
- Decided: Jun 4, 2015 after 247 days
- Product code: OUH (Skin Resurfacing Rf Applicator)
- 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: 1 generation back to K053365 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053365: Modification to Thermage Thermacool System, Thermage, Inc. (2005) Summary page 5.

## Indications for use
The INTRAgen is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Source page: https://510kreport.com/device/K142833
Methodology: https://510kreport.com/methodology