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Youmagic FLM System (YM5-U1)

We Medical Technology (Wuxi) Co., Ltd.

Country / Region:China (CN)Submission type:Traditional

Product code GEI· 21 CFR 878.4400

Summary PDF

Product code

GEI
21 CFR 878.4400

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K240857
Device name
Youmagic FLM System (YM5-U1)
Country / Region
China(CN)
Product code
GEI
Device class
Class 2
Regulation number
21 CFR 878.4400
Date received
2024-03-28
Decision date
2025-05-15
Submission type
Traditional
Technology type
RF Ablation(AI inferred)
Clinical applications
Surgery
Primary application
Surgery
Classification source
AI classified

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.

Intended 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.

Device Description

The Youmagic FLM System delivers RF energy for selective coagulation of tissue while conductively cooling the epidermis. The Youmagic FLM System delivers energy from the disposable tip to the patient. The System and its Handpiece monitor skin contact during treatment. The System employs RF tuning to provide RF energy across a range of impedances for delivery to the patient through single and multiple pass stamping motions of the tip. The Youmagic FLM System is a monopolar, conductive radiofrequency System designed for use in non-invasive dermatological procedures. The System consists of the following components: Console, including touchscreen, a Handpiece, Treatment Tip, and AC power cord. The System is used with the following WE Medical-supplied accessories: Cryogen Canister, Return Pad. The System continuously monitors output power, output energy, treatment duration, and measured impedance. The System also controls the coolant delivery through the Handpiece. The Handpiece delivers RF energy while cooling tissue by thermal conduction.

Summary parsed at:2026-06-20 17:45:00 UTC

Predicate devices

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