# K022839: Fotona Dualis Plus ND:Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.D.
- Decided: Nov 25, 2002 after 90 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.
251 later devices descend from it; 2 cite it directly.
0 of 252 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) Altus Medical A-esthetic Nd:YAG Laser: named in the summary without a submission number

## Most influential descendants
- K050293: Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of Laser Systems (2005), 200 descendants of its own
- K070355: Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family (2008), 194 descendants of its own
- K083889: Fotona QX ND:Yag/KTP Laser System Family (2009), 166 descendants of its own
- K103455: Spectra Laser System (2011), 92 descendants of its own
- K093162: Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis, Powerlase at / Fidelis ER Iii D, HT Fid (2010), 83 descendants of its own

## Indications for use
The Fatona DUAZIS" Plus Nd:YAG laser system 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-tenii, or permanent, hair reduction in skin types I .- VI through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment reginicn. For renioval of unwanted hair. For coagulation and hemostasis of vascular lesions. For incisiodescision of soft body tissue in deniiatology For soft tissue general surgery applications - skin incision; tissue dissectioii; complete or partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation

Source page: https://510kreport.com/device/K022839
Methodology: https://510kreport.com/methodology