# K202991: Fotona XPulse Pro Laser Platform

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.O.O.
- Decided: Jun 22, 2021 after 265 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: 23 generations back to K943450 (1995). 635 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 639 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193656: SkyPulse, Fotona D.O.O. (2020) Summary page 5.
- K073322: Fox 1-980, Fox Q-1064, Fox-Q-810, A.R.C Laser GmbH (2008) Summary page 5.
- K192272: Wolf445nm, A.R.C Laser GmbH (2020) Summary page 5.
- K180044: SIROLaser Blue, Dentsply Sirona (2018) Summary page 5.
- K083034: Fotona XD-2 Diode Laser System, Model MD01-2F, Fotona D.D. (2009) Summary page 5.

## Most influential descendants
- K221712: Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) (2022), 1 descendant of its own
- K232885: Dawn Diode Laser System (2024), 0 descendants of its own
- K220531: Fox 810, Fox 980 (2022), 0 descendants of its own

## Indications for use
810 nm Diode Laser System: * Incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following: o Gingival troughing for crown impression ° Gingivectomy ° Gingivoplasty ° Gingival incision and excision > Hemostasis and coagulation o Excisional and incisional biopsies o Fibroma removal o Frenectomy and frenotomy o Oral papillectomies ° Soft tissue crown lengthening o Treatment of aphthous ulcers o Treatment of herpetic lesions * Periodontology: o Laser soft tissue curettage, o Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket * Cosmetic Dentistry: o Laser-assisted bleaching/whitening of the teeth, o Light activation for bleaching materials for teeth whitening * Implant recovery * Surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology 810 nm Diode Laser Module: * Incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following: o Gingival troughing for crown impression °> Gingivoplasty o Soft tissue crown lengthening o Treatment of aphthous ulcers o Treatment of herpetic lesions 810 nm Diode Laser System & Module in therapy: * Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle. 980 nm Diode Laser: * Gingival troughing * Crown lengthening * Gingivoplasty * Coagulation * Hemostasis of donor site * Implant recovery * Implant uncovery * Soft tissue curettage * Sulcular debridement * Biopsy * Frenectomy * Operculectomy * Exposure of unerupted teeth * Pulpotomy * Treatment of aphthous ulcers * Excision of lesions * Light activation of bleaching materials for teeth whitening * Surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery. 445 nm Diode Laser: * Incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue

Source page: https://510kreport.com/device/K202991
Methodology: https://510kreport.com/methodology