# K013499: Diomed 15 Plus and Diomed 30PLUS Lasers

- Pathway: 510(k) (Special)
- Applicant: Diomed, Inc.
- Decided: Nov 16, 2001 after 25 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: 1 generation back to K962354 (1996). 1 ancestor in all.
298 later devices descend from it; 2 cite it directly.
0 of 300 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962354: Diomed 15, 30, 60 Surgical Diode Laser, Lifestream Int'L, Inc. (1996) Summary page 1.

## Most influential descendants
- 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
- 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

## Indications for use
The Diomed l5plus and Diomed 30plus lasers are indicated for contact and non-contact use for the following soft tissue app]ina’rinns: General Surgery Ophthamology/Oculoplastic Urology Gastroenterology Gynecology Otorhinolaryngology Pulmonary/T horacic Dermatology/ Plastic Surgery Neurosurgery (coagulation only) Ortl)opeclic

Source page: https://510kreport.com/device/K013499
Methodology: https://510kreport.com/methodology