Manufacturer
We Medical Technology (Wuxi) Co., Ltd.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
Product code
GEI
21 CFR 878.4400
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
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Cited as predicate
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