# K141986: Elux 810 Laser

- Pathway: 510(k) (Traditional)
- Applicant: Equipmed North America, Inc.
- Decided: Jan 30, 2015 after 192 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: 11 generations back to K910422 (1992). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123257: Emvera Diolux, Emvera Technologies, Inc. (2012) Summary page 4.

## Indications for use
The ELux810 Laser is indicated for hair removal, permanent hair reduction in people with Fitzpatrick skin type I-IV. It is also indicated for the treatment of benign superficial vascular and benign superficial pigmented lesions in people with Fitzpatrick skin type I-IV. 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 regimen.

Source page: https://510kreport.com/device/K141986
Methodology: https://510kreport.com/methodology