# K093162: Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis, Powerlase at / Fidelis ER Iii D, HT Fid - Pathway: 510(k) (Traditional) - Applicant: Fotona D.D. - Decided: Jan 22, 2010 after 108 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: 9 generations back to K910422 (1992). 106 ancestors in all. 83 later devices descend from it; 5 cite it directly. 0 of 190 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K001527: Fotona Fidelis ER: Yag Laser System and Accesories, Fotona D.D. (2000) Summary page 3. - K024204: Fotona Fidelis Plus ND:Yag Laser System, Fotona D.D. (2003) Summary page 3. - K050293: Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of Laser Systems, Fotona D.D. (2005) Summary page 3. - K021548: Fotona Dualis ND:Yag/ER:Yag Laser System, Fotona D.D. (2002) Summary page 3. - K041710: Versawave Dental ER:Yag Laser System, Hoya Conbio (2004) Summary page 3. - K040131: Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser System, New Star Lasers, Inc. (2004) Summary page 3. - K034011: Gemini Surgical Laser System & Accessories, Laserscope (2004) Summary page 3. - K030146: Kavo Key Laser 1242 and Kavo Key Laser 1243+, Kavo America (2005) Summary page 3. ## Most influential descendants - K101306: SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models M021-4AF/3, M002-2A (2011), 78 descendants of its own - K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own - K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own - K120235: Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo, Lightpod ND: Yag Lasers, Lightp (2012), 33 descendants of its own - K153671: Family of CoolGlide Aesthetic Lasers (2016), 32 descendants of its own ## Indications for use Er:YAG laser (2940 nm wavelength) 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 Er:YAG laser (2940 nm wavelength) in dermatology and other surgical areas: Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and skin resurfacing; 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 is necessary; Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy; Nd:YAG laser (1064 nm wavelength) in dentistry: Excisional and incisional biopsies Excision and vaporization of herpes simplex I and II Exposure of unerupted teeth Fibroma removal Frenectomy and frenotomy Gingival troughing for crown impressions Gingival incision and excision Gingivectomy Gingivoplasty Hemostasis Implant recovery Incision and drainage of abscess Laser assisted uvulopalatoplasty (LAUP) Operculectomy Oral papillectomies Pulpotomy and pulpotomy as an adjunct to root canal therapy Reduction of denture hyperplasia Reduction of gingival hypertrophy Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy Removal of post-surgical granulations Soft tissue crown lengthening 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) Tissue retraction for impression Treatment of aphtous ulcers Vestibuloplasty Nd:YAG laser (1064 nm wavelength) in dermatology and other surgical areas: Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types Fitzpatrick I-VI, including tanned skin Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasiae, rosacea, venous lake, leg veins and spider veins Treatment of wrinkles Treatment of mild to moderate inflammatory acne vulgaris Source page: https://510kreport.com/device/K093162 Methodology: https://510kreport.com/methodology