# K193656: SkyPulse - Pathway: 510(k) (Traditional) - Applicant: Fotona D.O.O. - Decided: Mar 27, 2020 after 88 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: 22 generations back to K943450 (1995). 632 ancestors in all. 11 later devices descend from it; 6 cite it directly. 0 of 644 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K191554: LightWalker Laser System Family, Fotona D.O.O. (2019) Summary page 7. - K190319: Waterlase Laser System Family, Biolase, Inc. (2019) Summary page 7. - K182088: XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro, Fotona D.O.O. (2018) Summary page 7. - K073322: Fox 1-980, Fox Q-1064, Fox-Q-810, A.R.C Laser GmbH (2008) Summary page 7. - K133006: Neov Diode Laser Family, G.N.S Neolaser, Ltd. (2014) Summary page 7. - K170500: SIROLaser Advance+, Dentsply Sirona (2017) Summary page 7. - K083034: Fotona XD-2 Diode Laser System, Model MD01-2F, Fotona D.D. (2009) Summary page 7. - K152939: Picasso Plus, Picasso Lite Plus, Amd Group, LLC (2015) Summary page 7. - K082707: Medx LPT 200 Tethered Laser & Medx LPS 200 (Oralase) Portable Laser, Medx Electronics, Inc. (2008) Summary page 7. - K083069: Ezlase 10W, Biolase Technology, Inc. (2008) Summary page 7. - K163128: Epic Pro, Biolase, Inc. (2017) Summary page 7. - K152722: neoV980 & neoV1470 Diode Lasers, G.N.S Neolaser, Ltd. (2015) Summary page 7. - K101916: Joule Multi-Platform System, Sciton, Inc (2011) Summary page 7. ## Most influential descendants - K202991: Fotona XPulse Pro Laser Platform (2021), 3 descendants of its own - K240179: Medical Diode Laser (Model: L2) (2024), 2 descendants of its own - K230274: Medical Diode Laser (M2) (2023), 2 descendants of its own - K241791: Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) (2025), 1 descendant of its own - K234004: Medical diode laser systems (CHARISMA, REGAL) (2025), 1 descendant of its own ## 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 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, cartillage, 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. 670 nm Diode Laser in low level laser therapy: -Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles. 808 nm Diode Laser in dentistry: Incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following: -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 808 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 of muscle. 980 nm Diode Laser in dentistry: -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 1470 nm Diode Laser: -Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue -Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux 1940 nm Diode Laser: -Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue Source page: https://510kreport.com/device/K193656 Methodology: https://510kreport.com/methodology