# K123257: Emvera Diolux

- Pathway: 510(k) (Traditional)
- Applicant: Emvera Technologies, Inc.
- Decided: Dec 14, 2012 after 57 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: 10 generations back to K910422 (1992). 58 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102716: Modified Alma Lasers Family of Soprano XL Multi-Application Platmforms, Alma Lasers, Inc. (2010) Summary page 1.

## Most influential descendants
- K152898: Diode Laser Therapy Systems (2016), 1 descendant of its own
- K191611: Diode Laser Therapy Systems (2019), 0 descendants of its own
- K141986: Elux 810 Laser (2015), 0 descendants of its own

## Indications for use
The Emvera Diolux is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and 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 regimen. Hair removal by laser or IPL sources can cause increase hair growth in some individuals. Based upon currently available data, the highest risk groups for this response are females of Mediterranean, Middle Eastern, and South Asian heritage treated on the face and neck. Caution: Federal (USA) law restricts this device for use by or on the order of a physician.

Source page: https://510kreport.com/device/K123257
Methodology: https://510kreport.com/methodology