# K021548: Fotona Dualis ND:Yag/ER:Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.D.
- Decided: Dec 6, 2002 after 207 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.
253 later devices descend from it; 5 cite it directly.
0 of 254 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) Fotona Dualis long pulse Nd:YAG 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

## Most influential descendants
- 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
- K113588: Spectra Laser System (2012), 82 descendants of its own

## Indications for use
Nd:YAG Laser (1064 nm) The Fotona DualisSP Nd:YAG laser is intended for incision, ablation, vaporization, and coagulation and hemostasis of vascular lesions and soft tissue in various surgical areas, and for permanent redudion of unwanted hair in Fitzpatrick skih types I VI. Dermatology: Coagulation and hemostasis of vascular lesions, and To effect stable long-term, 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 regimen. Plastic Sumem: Coagulation and vaporization of soft tissue. Otorinolarynqoloqv /Head and Neck (ENT): Tissue ablation and vessel hemostasis. Hemostasis durinq Sumery: Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscopic) and open procedures. Orthopedics: Ablation, vaporization, incision, excision, coagulation, and hernostasis of soft and cartilaginous tissue in small and large joints including but not limited to knee menisectomy, knee synovedomy, chondromaliacia and tears, shoulder debridement of scar tissue, and synovectomy of the shoulder. Neurosurqery: hemostasis in neurosurgery procedures such as excision of brain lesions, spinal cord lesions cranial nerves, peripheral nerves, and pituitary glands. Gastroenteroloqv: Tissue ablation and hemostasis in the gastrointestinal trad, cshophageal neoplastic obstructions including squamous cell carcinoma and adenocarcinoma; Gastrintestinal hemostatsis including varices, espohagitis, esopageat ulcer, Mallory-Weiss tear, gastric ulcer, stomac ulcers, angiodysplasia, non-bleeding ulcers, gastric erosions; Gastrintestinal tissue ablation including benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, hemorroids. 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 arid nodes, organs and glands. Dermatoloqy an Plastic Surqery Indications: Epidermal nevi, telangiectasias, spider veins, actinic sheilitis. keloids, verrucae, skin tags, anal tags, keratoses, scar revision, decubitis ulcers, and skin resurfacing. ENT Surqery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia Gynecoloqy Indications: Herpes simplex. endornaterial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, and condiloma. General Surqery 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'glossai lesions and gingivectomy Ophtalmoloqv Indications: Soft tissue surrounding the eye and orbit and anterior capsulotomy Pod.iatw Indications: Warts, plantar verrucae, large mosaic verrucae and matrixectomy Dentistw indications: Canes removal, cavity preparation, enamel etching

Source page: https://510kreport.com/device/K021548
Methodology: https://510kreport.com/methodology