# K192621: Medical RF

- Pathway: 510(k) (Traditional)
- Applicant: Triworks Group Srl
- Decided: Nov 6, 2020 after 410 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: 17 generations back to K943450 (1995). 90 ancestors in all.
No later device cites it as a predicate yet.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070004: Accent, Alma Lasers, Ltd. (2007) Summary page 4.
- K051214: Aluma Skin Renewal System, Lumenis, Inc. (2005) Summary page 4.
- K092191: Exilis, Model 5000, Btl Industries, Ltd. (2009) Summary page 4.

## Indications for use
The Medical RF is a non-invasive device intended for use in Dermatologic and General Surgical non-invasive treatment procedures of wrinkles and rhytides for I to IV Fitzpatrick Skin Types

Source page: https://510kreport.com/device/K192621
Methodology: https://510kreport.com/methodology