# K083034: Fotona XD-2 Diode Laser System, Model MD01-2F

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.D.
- Decided: Feb 4, 2009 after 117 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: 3 generations back to K011041 (2001). 7 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050453: Odyssey 2.4G, Denlaser Elite, Model 002-00050, Ivoclar Vivadent, Inc. (2005) Summary page 2.
- K011769: Opus 10 (with Tooth Whitening Application), Model 2ND, Opusdent, Ltd. (2001)

## Most influential descendants
- K193656: SkyPulse (2020), 11 descendants of its own
- K202991: Fotona XPulse Pro Laser Platform (2021), 3 descendants of its own
- K240179: Medical Diode Laser (Model: L2) (2024), 2 descendants of its own
- K230274: Medical Diode Laser (M2) (2023), 2 descendants of its own
- K241791: Medical Diode Laser Systems (GBOX-6H,  GBOX-10D , GBOX-12D,  GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) (2025), 1 descendant of its own

## Indications for use
Periodontology - Laser soft tissue curettage - Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket Oral Soft Tissue surgery - Gingivectomy - Gingivoplasty - Fibroma removal - Treatment of Aphthous Ulcers - Crown Lenghtening. - Frenectomy - Papillectomy - Photocoagulation Cosmetic Dentistry - Light activation for bleaching materials for teeth whitening - Lasers-assisted bleaching/whitening of the teeth

Source page: https://510kreport.com/device/K083034
Methodology: https://510kreport.com/methodology