# K011939: Fotona Dualis, Fotona Dualis Plus

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.D.
- Decided: Dec 27, 2001 after 189 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.
237 later devices descend from it; 4 cite it directly.
0 of 238 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) Coherent VersaPulse laser system: named in the summary without a submission number
- (no number) Laserscope Lyra laser system: named in the summary without a submission number
- (no number) other KTP (532 nm) lasers previously cleared for similar clinical applications: named in the summary without a submission number

## Most influential descendants
- K020697: Depilase Twin Yag Laser System (2002), 229 descendants of its own
- K032220: Adept 1064/532 Laser (2003), 126 descendants of its own
- K032218: Adept 1064/532/755 Laser (2003), 104 descendants of its own
- K083207: Ultrawave Iii EX 1320 (2008), 96 descendants of its own
- K062369: Iridex Oculight TX (2006), 73 descendants of its own

## Indications for use
The Fotona Dualis KTP (532 nm) Laser System and Accessories is intended for incision, ablation, vaporization, coagulation, and hemostasis of vascular lesions and soft tissue in various surgical areas. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands. Dermatology : The treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size) of the vascular lesions (Angiomas, Hemangiomas, Telangiectasia)

Source page: https://510kreport.com/device/K011939
Methodology: https://510kreport.com/methodology