# K013047: Fotona Dualis ND:Yag Laser System, Fotona Twinlight ND:Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Mojca Valijavec
- Decided: Dec 6, 2001 after 87 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 K003202 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010834: Lyra Series Surgical Laser System & Accessories, Laserscope (2001) Summary page 1.
- K003202: Family of Altus Medical Coolglide Aesthetic Lasers, Models I & II, Altus Medical (2001) Summary page 1.

## Indications for use
The family of Fotona DUALIS Nd:YAG laser systems is indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialities of general and plastic surgery and dermatology: . To effect stable long-term, or permanent, hair reduction in skin types I - VI through selective targeting of melanin in hair folliclcs. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a trcatment regimen. . For rcmoval of unwanted hair. . For coagulation and hemostasis of vascular lesions. . For incision/excision of soft body tissue in dermatology . For soft tissue general surgery applications - skin incision; tissue dissection; complete or partial resection of intcrnal organs, tumors, lesions; tissue ablation; vessel coagulation

Source page: https://510kreport.com/device/K013047
Methodology: https://510kreport.com/methodology