Manufacturer
Wontech Co., Ltd.Oligio X
Country / Region:Korea, Republic of (KR)Submission type:Special
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
- K243929
- Device name
- Oligio X
- Company
- Wontech Co., Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2024-12-20
- Decision date
- 2025-01-21
- Submission type
- Special
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- SurgeryOther
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
Oligio X is intended for use in dermatologic and general surgical procedures for non-invasive electrocoagulation and hemostasis of soft tissue. Anatomical site: Skin and soft tissue.
Intended Use
Oligio X is intended for use in dermatologic and general surgical procedures for non-invasive electrocoagulation and hemostasis of soft tissue.
Device Description
Oligio X is a radio frequency therapy system. The radio frequency output of the device is 6.78 MHz, and the maximum power is 200 W. Oligio X consists of a main body including touch LCD monitor, a RF handpiece, return pads, a return pad cable, non-sterile treatment tips, cooling gas, coupling fluids, footswitch and a power cable. Oligio X RF System delivers radio frequency energy for selective coagulation of tissue while conductively cooling the epidermis. Oligio X delivers energy from the disposable tip to the patient, and employs radio frequency turning to provide radio frequency energy across a range of impedances for delivery to the patient through the tip.
Summary parsed at:2026-06-20 17:54:25 UTC
Predicate devices
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K243929 references 1 predicate/reference device
Cited as predicate
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