Manufacturer
Hironic Co., Ltd.NEW DOUBLO 2.0
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
- K251334
- Device name
- NEW DOUBLO 2.0
- Company
- Hironic Co., Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-04-30
- Decision date
- 2025-09-29
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- SurgeryTissue Repair
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
The NEW DOUBLO 2.0 with RM and RM(B) handpiece is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis. The NEW DOUBLO 2.0 with PS handpiece is intended for the removal and destruction of skin lesions and coagulation of tissue.
Intended Use
The NEW DOUBLO 2.0 with RM and RM(B) handpiece is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis. The NEW DOUBLO 2.0 with PS handpiece is intended for the removal and destruction of skin lesions and coagulation of tissue.
Device Description
This device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, three handpieces, foot switch, LCD touchscreen and power cable. The device is intended for use by trained healthcare professionals in a clinical setting to provide controlled radiofrequency therapy through non-invasive procedure. RF uses electromagnetic wave frequencies to generate an electric field within tissue to cause heating. The amount of energy delivered to tissue is proportional to the current, time, and resistance within the tissue, also known as impedance. High frequency amplification is performed and it is transmitted to the handpiece. The corresponding output is controlled through the Foot Switch and Hand Switches, and when the Foot Switch and Hand Switches are pressed, each handpiece irradiates the transmitted high-frequency energy to the skin.
Summary parsed at:2026-06-20 17:49:19 UTC