# K022838: Fotona Dualis ER:Yag/KTP 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Fotona Dualis long pulse KTP laser system: named in the summary without a submission number
- (no number) Fotona Fidelis Er:YAG laser system: named in the summary without a submission number

## Indications for use
KTP Laser (532nm) The FotonA DualisW KTP laser 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. Dermatoloav: The treatment (hemostasis, color lightening, blanching, flattening, reduction of lesiori size) of the vascular lesions (Angiomas, Hemangiomas, Telangiectasia) Er:YAG Laser (2940 nm) The Fotona Dualis'" Er:YAG laser is intended for surgical incision/excision, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, subcutaneous tissue, striated and smooth tissue, cartilage meniscus, muscle, mucous membrane, lymph vessels and nodes, organs and glands. Dermatoloqv an Plastic Surgery Indications: Epidermal nevi, telangiectasias, spider veins, actinic sheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, decubitis ulcers, and skin resurfacing. ENT Suraery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia Gvnecoloav Indications: Herpes simplex, endomaterial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, and condiloma. General Suraety Indications: Surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation. Oral/Maxillofacial Indications: Oral and glossal lesions and gingivectomy Ophtalrnoloqv Indications: Soft tissue surrounding the eye and orbit and anterior ca 3sulotomy Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae and matrixectomy Dentistry indications: Caries removal, cavity preparation, enamel etching

Source page: https://510kreport.com/device/K022838
Methodology: https://510kreport.com/methodology