# K063828: Diomed Delta 25

- Pathway: 510(k) (Special)
- Applicant: Diomed, Ltd.
- Decided: Jan 25, 2007 after 30 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 K943450 (1995). 132 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051996: Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30, Diomed, Ltd. (2005)
- K032218: Adept 1064/532/755 Laser, Adept Medical Concepts (2003) Summary page 1.
- K023881: Profile 1064 Laser System, Sciton, Inc (2003) Summary page 1.
- K020021: Lyra Surgical Laser System and Accessiories (ND:Yag Configuration), Laserscope (2002) Summary page 1.
- K981952: Combination ND:Yag and Frequency Doubled Solid State Green Laser, Instruments For Medicine and Diagnostics (1998) Summary page 1.

## Most influential descendants
- K080959: Dornier Medilas D 30 Laser, Medilas D 1064 (2008), 4 descendants of its own
- K181510: Echolaser X4 (2018), 3 descendants of its own
- K213594: Echolaser X4 (2022), 1 descendant of its own
- K261964: Echolaser X4 (2026), 0 descendants of its own
- K260632: Laser Thermal Therapy Kit (2026), 0 descendants of its own

## Indications for use
Ablation, incision, excision, coagulation and vaporisation of soft tissues in the following open and endoscopic surgical procedures: * General Surgery * Ophthalmology/Oculoplastic * Urology * Gastroenterology * Gynecology * Otorhinolaryngology * Pulmonary/Thoracic * Dermatology/Plastic Surgery * Neurosurgery (coagulation only) * Orthopedic

Source page: https://510kreport.com/device/K063828
Methodology: https://510kreport.com/methodology