# K012398: Diomed 15 Diode Laser

- Pathway: 510(k) (Traditional)
- Applicant: Diomed, Ltd.
- Decided: Jan 22, 2002 after 179 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: 7 generations back to K943450 (1995). 22 ancestors in all.
714 later devices descend from it; 6 cite it directly.
0 of 737 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974521: Vnus Closure System, Vnus Medical Technologies, Inc. (1998) Summary page 1.
- K003092: Modification to Vnus Closure System, Vnus Medical Technologies, Inc. (2000) Summary page 1.
- K982816: Vnus Closure System, Vnus Medical Technologies, Inc. (1999) Summary page 1.

## Most influential descendants
- K020339: Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser System (2002), 695 descendants of its own
- K030186: Polris LV (2003), 680 descendants of its own
- K031671: Polaris WR (2003), 678 descendants of its own
- K051214: Aluma Skin Renewal System (2005), 476 descendants of its own
- K052324: Polaris LV, Lva Applicator (2005), 456 descendants of its own

## Indications for use
Diomed 810 nm Surgical Lasers and EVLT Procedure Kit are intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

Source page: https://510kreport.com/device/K012398
Methodology: https://510kreport.com/methodology