# K141507: Two Skin Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Syneron Medical, Ltd.
- Decided: Dec 8, 2014 after 185 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: 18 generations back to K943450 (1995). 258 ancestors in all.
No later device cites it as a predicate yet.
0 of 259 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110672: Etwo Skin Treatment System, Syneron, Ltd. (2011) Summary page 4.
- K120513: Glow by Endymed, Endymed Medical, Ltd. (2012) Summary page 4.
- K083461: Imagine TC Skin Therapy System, Endymion Medical, Ltd. (2009) Summary page 4.
- K101510: Fractional Skin Resurfacing (FSR) Applicator, Endymed Medical, Ltd. (2011) Summary page 4.

## 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. At higher energy levels greater than 62 mJ/pin, the Sublative RF applicator is limited to skin types I-IV. The Sublime applicator is indicated for non-invasive wrinkles treatment. At higher energy levels greater than 100 J/cm3, the Sublime applicator is limited to skin types I-IV.

Source page: https://510kreport.com/device/K141507
Methodology: https://510kreport.com/methodology