# K110672: Etwo Skin Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Syneron, Ltd.
- Decided: Oct 3, 2011 after 208 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: 17 generations back to K943450 (1995). 255 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 258 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090025: Matrix RF Applicator, Syneron Medical, Ltd. (2010) Summary page 2.
- K053616: Polaris WR, ST Applicator, Syneron Medical, Ltd. (2006) Summary page 2.
- K083461: Imagine TC Skin Therapy System, Endymion Medical, Ltd. (2009) Summary page 2.

## Most influential descendants
- K141507: Two Skin Treatment System (2014), 0 descendants of its own
- K113868: Eplus Skin Treatment System (2012), 0 descendants of its own

## Indications for use
The eTwo Skin Treatment system is intended for dermatological procedures. The Sublative RF applicator is indicated for Dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. The Sublime applicator is indicated for non invasive wrinkles treatment.

Source page: https://510kreport.com/device/K110672
Methodology: https://510kreport.com/methodology