# K213261: EpilME

- Pathway: 510(k) (Traditional)
- Applicant: Neauvia North America
- Decided: Jun 2, 2022 after 245 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: 12 generations back to K910422 (1992). 107 ancestors in all.
No later device cites it as a predicate yet.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170179: LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity, Lumenis, Ltd. (2017) Summary page 4.

## Indications for use
Laser EpilME with EpilME applictor is indicated for use in surgical and aesthetic applications in the medical specialties of general and plastic surgery, and dermatology. The EpilME is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin. The EpilMe with EpilME Applicator is intended for: * Treatment of benign vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions and leg veins * Treatment of pseudofolliculitis barbae (PFB) * Hair removal, permanent hair reduction* * Treatment of benign pigmented lesions *Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Source page: https://510kreport.com/device/K213261
Methodology: https://510kreport.com/methodology