# K240311: JETT Medical II

- Pathway: 510(k) (Traditional)
- Applicant: Compex, Spol, S.R.O.
- Decided: Jan 22, 2025 after 355 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: 18 generations back to K943450 (1995). 95 ancestors in all.
No later device cites it as a predicate yet.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102698: Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve Glidesafe, Ellman Int'L, Inc. (2011) Summary page 5.

## Indications for use
JETT Medical II is intended for non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV.

Source page: https://510kreport.com/device/K240311
Methodology: https://510kreport.com/methodology