SkyPulse

Fotona D.O.O.

Country / region:Slovenia (SI)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Slovenia (SI)

Product code

GEX
21 CFR 878.4810

Predicate devices

13

Cited as predicate

6

Device details

FDA 510(k) registration fields

K number
K193656
Device name
SkyPulse
Country / region
Slovenia(SI)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2019-12-30
Decision date
2020-03-27
Submission type
Traditional
Technology type
Er:YAG(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

2940 nm Er:YAG Laser in dentistry:
-Intra-oral soft tissue surgery (incision, excision, ablation, coagulation)
-Leukoplakia
-Pulpotomy as adjunct to root canal retreatment
-Pulp extirpation
-Removal of fibromae
-Removal of granulated tissue
-Caries removal, cavity preparation, enamel roughening
-Sulcular debridement
-Tooth preparation to obtain access to root canal, root canal debridement and cleaning, root canal preparation including enlargement
-Cutting, shaving, contouring and resection of oral osseous tissue (bone)
-Osteotomy, osseous crown lengthening, osteoplasty
-Apicectomy surgery
-Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage
-Laser removal of porcelain and ceramic crowns and veneers
-Flap preparation – incision of soft-tissue to prepare a flap and expose the bone
-Cutting bone to prepare a window access to the apex (apices) of the root(s)
-Root-end preparation for retrofill
-Full thickness flap
-Partial thickness flap
-Split thickness flap
-Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket
-Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium
-Excisional and incisional biopsies
-Flap preparation – incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions)
-Frenectomy and frenotomy
-Gingival troughing for crown impressions
-Gingivoplasty
-Implant recovery
-Root canal debridement and cleaning
-Soft tissue crown lengthening
-Laser root canal disinfection after endodontic treatment

2940 nm Er:YAG Laser in dermatology and other surgical areas:
-Dermatology and Plastic Surgery Indications: Skin resurfacing, epidermal nevi, verrucae, skin tags, keratoses, treatment of wrinkles
-ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia
-Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectomy
-General Surgery 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
-Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae
-Ophthalmology Indications: Soft tissue surrounding the eye
-Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma
-Genitourinary Indications: Lesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon

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 

Intended Use

The Fotona SkyPulse Laser Platform, and its accessories, will be marketed for the following indications: 2940 nm Er:YAG Laser in dentistry: • Intra-oral soft tissue surgery (incision, excision, ablation, coagulation) • Leukoplakia • Pulpotomy as adjunct to root canal retreatment • Pulp extirpation • Removal of fibromae • Removal of granulated tissue • Caries removal, cavity preparation, enamel roughening • Sulcular debridement • Tooth preparation to obtain access to root canal, root canal debridement and cleaning, root canal preparation including enlargement • Cutting, shaving, contouring and resection of oral osseous tissue (bone) • Osteotomy, osseous crown lengthening, osteoplasty • Apicectomy surgery • Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage • Laser removal of porcelain and ceramic crowns and veneers • Flap preparation – incision of soft-tissue to prepare a flap and expose the bone • Cutting bone to prepare a window access to the apex (apices) of the root(s) • Root-end preparation for retrofill • Full thickness flap • Partial thickness flap • Split thickness flap • Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket • Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium • Excisional and incisional biopsies • Flap preparation – incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions) • Frenectomy and frenotomy • Gingival troughing for crown impressions • Gingivoplasty • Implant recovery • Root canal debridement and cleaning • Soft tissue crown lengthening • Laser root canal disinfection after endodontic treatment 2940 nm Er:YAG Laser in dermatology and other surgical areas: • Dermatology and Plastic Surgery Indications: Skin resurfacing, epidermal nevi, verrucae, skin tags, keratoses, treatment of wrinkles. • ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia • Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectomy • General Surgery 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 • Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae • Oph

Device Description

The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attachable laser modules. The Fotona SkyPulse Laser Platform is a multi-application, multi-technology platform that supports the following modules: i) Flash-lamp pumped solid state laser modules and ii) Diode laser modules. 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. The console allows simultaneous attachment of a solid state laser module and a diode module with up to three selectable diode laser wavelengths. The following therapeutic laser modules are currently available with the SkyPulse platform: 2940 nm Er:YAG Laser Module, 1064 nm Diode Laser Module, 808 nm Diode Laser Module, 670 nm Diode Laser Module, 980 nm Diode Laser Module, 1470 nm Diode Laser Module and 1940 nm Diode Laser Module. A diode aiming beam is combined with all therapeutic laser beams. The combined therapeutic and aiming beams are guided either through an articulated arm to an optical handpiece (in the case of the Er:YAG laser), or through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end.

Summary parsed at:2026-06-01 05:47:32 UTC

Predicate devices

13

K193656 references 13 predicate/reference devices

Cited as predicate

6

6 submissions cite K193656 as a predicate