# K133405: Minnie

- Pathway: 510(k) (Traditional)
- Applicant: Elettronica Valseriana Srl
- Decided: May 23, 2014 after 198 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: 16 generations back to K943450 (1995). 89 ancestors in all.
No later device cites it as a predicate yet.
0 of 90 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 1.
- K083461: Imagine TC Skin Therapy System, Endymion Medical, Ltd. (2009) Summary page 1.
- K100586: Venus Freeze System, Venus Concept, Ltd. (2010) Summary page 1.

## Indications for use
Non-ablative treatment of mild to moderate facial wrinkles and rhytides. This device has not been tested on darker skin subjects

Source page: https://510kreport.com/device/K133405
Methodology: https://510kreport.com/methodology