# K113868: Eplus Skin Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Syneron, Ltd.
- Decided: Jun 11, 2012 after 164 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- 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). 271 ancestors in all.
No later device cites it as a predicate yet.
0 of 272 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041959: Polaris DS/Comet, Syneron Medical, Ltd. (2004) Summary page 3.
- K030186: Polris LV, Syneron Medical, Ltd. (2003) Summary page 3.
- K031671: Polaris WR, Syneron Medical, Ltd. (2003) Summary page 3.
- K031993: Aurora SR, Syneron Medical, Ltd. (2003) Summary page 3.
- K032514: AC Applicator, Aurora AC, Syneron Medical, Ltd. (2004) Summary page 3.
- K050796: Aurora DS, DS Applicator, Syneron Medical, Ltd. (2005) Summary page 3.
- K050452: Aurora SR and Sra Applicator, Syneron Medical, Ltd. (2005) Summary page 3.
- K052324: Polaris LV, Lva Applicator, Syneron Medical, Ltd. (2005) Summary page 3.
- K110672: Etwo Skin Treatment System, Syneron, Ltd. (2011) Summary page 3.

## Indications for use
The ePlus Skin Treatment system is intended for dermatological procedures. The DS applicator is indicated for the removal of unwanted hair from skin types I-VI. and to effect stable long-term, or permanent, hair reduction* The DSL applicator is indicated for hair removal, permanent hair reduction*. The applicator is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin. The LV applicator is indicated for treatment of vascular lesions. The LVA applicator is indicated for treatment of vascular lesions. The WRA applicator is indicated for non invasive wrinkles treatment. The SR applicator is intended for superficial benign vascular and pigmented lesion treatment such as: lentigines, freckles, telangiectasia, rosacea, poikiloderma, angioma, sun spots and age spots. The SR treatment may be performed on body areas such as the face, chest, hands and arms. It can be also performed on sporadic lesions anywhere on the body. The SRA applicator is intended for superficial benign vascular and pigmented lesion treatment such as: lentigines, freckles, telangiectasia, rosacea, poikiloderma, angioma, sun spots and age spots. The SRA treatment may be performed on body areas such as the face, chest, hands and arms. It can be also performed on sporadic lesions anywhere on the body. The AC applicator is indicated for the treatment of moderate inflammatory acne vulgaries. The Sublative RE 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. *Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen

Source page: https://510kreport.com/device/K113868
Methodology: https://510kreport.com/methodology