# K962354: Diomed 15, 30, 60 Surgical Diode Laser

- Pathway: 510(k) (Traditional)
- Applicant: Lifestream Int'L, Inc.
- Decided: Sep 11, 1996 after 85 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.
300 later devices descend from it; 2 cite it directly.
0 of 301 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 its predicate without a number.
- (no number) Diomed 25 Surgical Diode Laser: named in the summary without a submission number

## Most influential descendants
- K013499: Diomed 15 Plus and Diomed 30PLUS Lasers (2001), 298 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
- 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

## Indications for use
The Diomed Surgical Diode Laser is intended for use in delivering 15, 30, or 60 Watts of continuous wave radiation to a flexible optical fiber, for use in ablation, incision, excision, coagulation, and vaporization of soft tissue in open and endoscopic surgical procedures.

Source page: https://510kreport.com/device/K962354
Methodology: https://510kreport.com/methodology