# K051996: Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30

- Pathway: 510(k) (Special)
- Applicant: Diomed, Ltd.
- Decided: Aug 18, 2005 after 24 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: 9 generations back to K943450 (1995). 27 ancestors in all.
89 later devices descend from it; 5 cite it directly.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013499: Diomed 15 Plus and Diomed 30PLUS Lasers, Diomed, Inc. (2001) Summary page 1.
- K012398: Diomed 15 Diode Laser, Diomed, Ltd. (2002) Summary page 1.
- K023543: Evlt Kit and D15PLUS and D30PLUS Diode, Diomed, Inc. (2002) Summary page 1.
- K041957: Evlt Kit and the D15PLUS and D30PLUS Diode Lasers, Diomed, Inc. (2004) Summary page 1.

## Most influential descendants
- K090126: Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model MOO1-14F, MOO1-14F, MOO1-14F/2, (2009), 80 descendants of its own
- K101306: SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models M021-4AF/3, M002-2A (2011), 78 descendants of its own
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own
- K120235: Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo, Lightpod ND: Yag Lasers, Lightp (2012), 33 descendants of its own

## Indications for use
General Surgery Ophthalmology/Oculoplastic Urology Gastroenterology Gynecology Otorhinolaryngology Pulmonary/Thoracic Dermatology/Plastic Surgery Neurosurgery (coagulation only) Orthopedic Treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein. Treatment of incompetent refluxing veins in the superficial venous system in the lower limb

Source page: https://510kreport.com/device/K051996
Methodology: https://510kreport.com/methodology