Manufacturer
Agnes Medical Co., Ltd.AGNES Ultra
Country / Region:Korea, Republic of (KR)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
- K250217
- Device name
- AGNES Ultra
- 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
- 2025-01-24
- Decision date
- 2025-09-03
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- SurgeryOther
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
AGNES RF (DL) handpiece, AGNES RF (F) handpiece and AGNES RF (B) handpiece of AGNES Ultra are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Intended Use
AGNES RF (DL) handpiece, AGNES RF (F) handpiece and AGNES RF (B) handpiece of AGNES Ultra are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Device Description
AGNES Ultra 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, handpieces, single use electrodes, Neutral electrode pad, NE pad cable, foot switch. RF energy handpiece is AGNES RF (DL) handpiece, AGNES RF (F) handpiece and AGNES RF (B) handpiece that delivers RF energy through the disposable electrode in the handpiece.
Summary parsed at:2026-06-20 17:47:37 UTC
Predicate devices
5Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K250217 as a predicate