Manufacturer
Agnes Medical Co., Ltd.RFMagik Lite
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Device details
FDA 510(k) registration fields
- K number
- K242469
- Device name
- RFMagik Lite
- Company
- Agnes Medical Co., Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2024-08-20
- Decision date
- 2025-04-25
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- SurgeryOther
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
RFMagik Lite is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Intended Use
RFMagik Lite is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Device Description
RFMagik Lite is a medical device combined with RF current, to function as an electrosurgical device for use in dermatology and general surgical procedures. It is possible to select and change modes, parameters, outputs, etc. using the panel on the main body. It consists of the main device, LCD screen, two handpieces, single use electrodes, electrode pad, NE pad cable, foot switch. There are two handpieces: RO handpiece and AGNES RF handpiece that delivers RF energy through the disposable electrode in the handpiece.
Summary parsed at:2026-06-20 17:45:16 UTC
Predicate devices
5Cited as predicate
2Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)
AGNES Ultra
2 submissions cite K242469 as a predicate