# K041957: Evlt Kit and the D15PLUS and D30PLUS Diode Lasers

- Pathway: 510(k) (Traditional)
- Applicant: Diomed, Inc.
- Decided: Dec 1, 2004 after 133 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K943450 (1995). 26 ancestors in all.
297 later devices descend from it; 4 cite it directly.
0 of 324 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023543: Evlt Kit and D15PLUS and D30PLUS Diode, Diomed, Inc. (2002) Summary page 1.
- K012398: Diomed 15 Diode Laser, Diomed, Ltd. (2002)
- K013499: Diomed 15 Plus and Diomed 30PLUS Lasers, Diomed, Inc. (2001) Summary page 1.

## Most influential descendants
- K072034: Diode Medical Laser Family, Models 4, 6, 30 (2007), 263 descendants of its own
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own
- K062822: Vari-Lase Endovenous Laser Console, Model 7500 (2006), 132 descendants of its own
- K070388: Profile Multi-Platform System (2007), 129 descendants of its own
- K081352: Profile Multi-Platform System (2008), 112 descendants of its own

## Recalls of this device
- Aug 10, 2022 · Class II · Z-1819-2022: OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional specification, may result in damage to the sheath, including separation or the inability to move 

## Indications for use
The 810nm Diomed Laser and EVLT Procedure Kit are intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Diomed D15 plus and D30 plus and EVLT Kits are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.

Source page: https://510kreport.com/device/K041957
Methodology: https://510kreport.com/methodology