Manufacturer
Eunsung Global CorpDUET-V (Model: ESK-3261DV)
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
- K233118
- Device name
- DUET-V (Model: ESK-3261DV)
- Company
- Eunsung Global Corp
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2023-09-27
- Decision date
- 2025-01-03
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- SurgeryOther
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
The radiofrequency energy delivery components of the DUET-V(ESK-3261DV) and Accessories are indicated for use in: - Fractional Tips (FRF Tips): Fractional Tip is intended for use in dermatological procedures requiring ablation and resurfacing of the skin. - Thermal Tips (TRF Tips): Dermatologic and general surgical procedures for electrocoagulation.
Intended Use
The radiofrequency energy delivery components of the DUET-V(ESK-3261DV) and Accessories are indicated for use in: - Fractional Tips (FRF Tips): Fractional Tip is intended for use in dermatological procedures requiring ablation and resurfacing of the skin. - Thermal Tips (TRF Tips): Dermatologic and general surgical procedures for electrocoagulation.
Device Description
DUET-V (Model: ESK-3261DV) is classified under 21 CFR 878.4400 as an Electrosurgical cutting and coagulation device and accessories. It is a Class 2 device.
Summary parsed at:2026-06-20 17:44:51 UTC