Manufacturer
Fotona D.O.O.Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)
Country / Region:Slovenia (SI)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K221712
- Device name
- Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)
- Company
- Fotona D.O.O.
- Country / Region
- Slovenia(SI)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-06-13
- Decision date
- 2022-10-12
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
1064 nm Diode Laser in dentistry: • Excisional and incisional biopsies • Excision and vaporization of herpes simplex I and II • Frenectomy and frenotomy • Gingivectomy • Gingivoplasty • Gingival incision and excision • Hemostasis • Implant recovery • Operculectomy • Pulpotomy and pulpotomy as an adjunct to root canal therapy • Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy • Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility) • Treatment of aphthous ulcers and herpetic lesions 1064 nm Diode Laser in dermatology and other surgical areas: • General surgery indications: surgical incision, excision, vaporization and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal. • Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: Matrixectomy, Periungual and subungual warts, Plantar warts, Radical nail excision, Neuromas. • Temporary increase of clear nail in patients with onychomycosis (e.g. dermatophytes Trichophyton rubrum and T mentagrophytes and/or yeasts Candida albicans, etc.) 1064 nm Diode Laser in therapy: • Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle. 810 nm Diode Laser in dentistry: • 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 • Oral/maxillofacial Indications: Incision, excision, vaporization, ablation and coagulation of oral soft tissue ◦ Gingival troughing for crown impression ◦ Gingivectomy ◦ Gingivoplasty ◦ Gingival incision and excision ◦ Hemostasis and coagulation ◦ Excisional and incisional biopsies ◦ Fibroma removal ◦ Frenectomy and frenotomy ◦ Oral papillectomies ◦ Soft tissue crown lengthening ◦ Treatment of aphthous ulcers ◦ Treatment of herpetic lesions • Periodontology: ◦ Laser soft tissue curettage, ◦ Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket • Cosmetic Dentistry: ◦ Laser-assisted bleaching/whitening of the teeth, ◦ Light activation for bleaching materials for teeth whitening • Implant recovery 810 nm Diode Laser 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 o
Intended Use
1064 nm Diode Laser in dentistry: • Excisional and incisional biopsies • Excision and vaporization of herpes simplex I and II • Frenectomy and frenotomy • Gingivectomy • Gingivoplasty • Gingival incision and excision • Hemostasis • Implant recovery • Operculectomy • Pulpotomy and pulpotomy as an adjunct to root canal therapy • Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy • Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility) • Treatment of aphthous ulcers and herpetic lesions 1064 nm Diode Laser in dermatology and other surgical areas: • General surgery indications: surgical incision, excision, vaporization and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal. • Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: Matrixectomy, Periungual and subungual warts, Plantar warts, Radical nail excision, Neuromas. • Temporary increase of clear nail in patients with onychomycosis (e.g. dermatophytes Trichophyton rubrum and T mentagrophytes and/or yeasts Candida albicans, etc.) 1064 nm Diode Laser in therapy: • Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle. 810 nm Diode Laser in dentistry: • 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 • Oral/maxillofacial Indications: Incision, excision, vaporization, ablation and coagulation of oral soft tissue ◦ Gingival troughing for crown impression ◦ Gingivectomy ◦ Gingivoplasty ◦ Gingival incision and excision ◦ Hemostasis and coagulation ◦ Excisional and incisional biopsies ◦ Fibroma removal ◦ Frenectomy and frenotomy
Device Description
The Fotona XPulse Laser System Family is a multi-application, multi-technology laser system family that supports the diode laser technology. A diode aiming beam is combined with all therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end. The Fotona XPulse Laser System Family consists of a console and a footswitch. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system micro-controller through an LCD touch-screen. A diode aiming beam is combined with all therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end. The following wavelengths are currently available with the XPulse System Family: 810 nm, 980 nm and 1064 nm. The following handpieces are to be used with Fotona XPulse Laser System Family: R21 (variants C2, C3, SHP and EHP), R26 (variants: black, green, blue, silver and red), Genova- and MarcCo (variants S, M and L).
Summary parsed at:2026-06-01 05:40:10 UTC
Predicate devices
3SkyPulse
LightWalker Laser System Family
Fotona XPulse Pro Laser Platform
K221712 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K221712 as a predicate
