# K023543: Evlt Kit and D15PLUS and D30PLUS Diode

- Pathway: 510(k) (Traditional)
- Applicant: Diomed, Inc.
- Decided: Dec 2, 2002 after 41 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
No predicates in its family tree.
345 later devices descend from it; 8 cite it directly.
0 of 346 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K040294: Laserpro Diode Laser Systems, Models 810, 940 & 980 (2004), 306 descendants of its own
- K042211: Modification to: Laserpro 810, 940, and 980 Diode Diode Laser Systems (2004), 303 descendants of its own
- K053540: Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene (2006), 299 descendants of its own
- K041957: Evlt Kit and the D15PLUS and D30PLUS Diode Lasers (2004), 297 descendants of its own
- K072034: Diode Medical Laser Family, Models 4, 6, 30 (2007), 263 descendants of its own

## Indications for use
EVLT kits and Diomed DlSplus and D30plus Diode Lasers are indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein

Source page: https://510kreport.com/device/K023543
Methodology: https://510kreport.com/methodology