# K240857: Youmagic FLM System (YM5-U1)

- Pathway: 510(k) (Traditional)
- Applicant: We Medical Technology (Wuxi) Co., Ltd.
- Decided: May 15, 2025 after 413 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: 20 generations back to K943450 (1995). 119 ancestors in all.
No later device cites it as a predicate yet.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170758: Thermage FLX System and Accessories, Solta Medical (2017) Summary page 6.

## Indications for use
The radiofrequency-energy only delivery components of the Youmagic FLM System are indicated for use in dermatologic surgical procedures for electrocoagulation and hemostasis. The Youmagic FLM System is a prescription use device.

Source page: https://510kreport.com/device/K240857
Methodology: https://510kreport.com/methodology