# K070355: Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family - Pathway: 510(k) (Traditional) - Applicant: Fotona D.D. - Decided: Mar 4, 2008 after 392 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. 194 later devices descend from it; 4 cite it directly. 0 of 301 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 7. - K024204: Fotona Fidelis Plus ND:Yag Laser System, Fotona D.D. (2003) Summary page 7. - 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 7. - K021548: Fotona Dualis ND:Yag/ER:Yag Laser System, Fotona D.D. (2002) Summary page 7. - K041710: Versawave Dental ER:Yag Laser System, Hoya Conbio (2004) Summary page 7. - K030290: Periolase ND:Yag Dental Laser System, Millennium Dental Technologies, Inc. (2004) Summary page 7. - K040131: Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser System, New Star Lasers, Inc. (2004) Summary page 7. - K034011: Gemini Surgical Laser System & Accessories, Laserscope (2004) Summary page 7. ## Most influential descendants - K083889: Fotona QX ND:Yag/KTP Laser System Family (2009), 166 descendants of its own - K103455: Spectra Laser System (2011), 92 descendants of its own - K113588: Spectra Laser System (2012), 82 descendants of its own - K090126: Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model MOO1-14F, MOO1-14F, MOO1-14F/2, (2009), 80 descendants of its own - 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 ## 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 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; 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 Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscess Laser assisted uvulopaletoplasty (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 imflamed 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 Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium) 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-V1, including tanned skin Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins Treatment of wrinkles Treatment of mild to moderate inflammatory acne vulgaris Source page: https://510kreport.com/device/K070355 Methodology: https://510kreport.com/methodology