# K233118: DUET-V (Model: ESK-3261DV)

- Pathway: 510(k) (Traditional)
- Applicant: Eunsung Global Corp
- Decided: Jan 3, 2025 after 464 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K943450 (1995). 288 ancestors in all.
No later device cites it as a predicate yet.
0 of 289 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173759: Thermage CPT System and Accessories, Solta Medical (2018) Summary page 5.
- K201164: Venus Viva MD Device, Venus Concept USA, Inc. (2020) Summary page 5.

## 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. - Thernal Tips (TRF Tips): Dermatologic and general surgical procedures for electrocoagulation

Source page: https://510kreport.com/device/K233118
Methodology: https://510kreport.com/methodology