# K090126: Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model MOO1-14F, MOO1-14F, MOO1-14F/2, - Pathway: 510(k) (Traditional) - Applicant: Fotona D.D. - Decided: Jun 29, 2009 after 159 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: 10 generations back to K943450 (1995). 146 ancestors in all. 80 later devices descend from it; 6 cite it directly. 0 of 227 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K070355: Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family, Fotona D.D. (2008) Summary page 3. - K030290: Periolase ND:Yag Dental Laser System, Millennium Dental Technologies, Inc. (2004) Summary page 3. - K061618: Cooltouch, Model Ctev, New Star Lasers, Inc. (2006) Summary page 4. - K073427: Medilas D Family Lasers, Dornier Medtech America, Inc. (2008) Summary page 4. - K051996: Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30, Diomed, Ltd. (2005) Summary page 4. - K062321: Smartlipo ND:Yag Laser, Cynosure, Inc. (2006) Summary page 4. - K080121: Cynosure Smartlipo Multiwavlength Laser, Cynosure, Inc. (2008) Summary page 4. - K073715: ELIPO, Syneron Medical, Ltd. (2008) Summary page 4. - K033172: Candela Gentleyag Family of Laser Systems, Candela Corp. (2003) Summary page 4. - K040131: Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser System, New Star Lasers, Inc. (2004) Summary page 4. - K034011: Gemini Surgical Laser System & Accessories, Laserscope (2004) Summary page 4. ## 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 Nd:YAG laser (1064 nm wavelength) in dermatology and other surgical areas: - Surgical incison, excision, vaporization,, ablation 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. It is further indicated for laser assisted lipolysis - 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 - Treatment of wrinkles - Treatment of mild to moderate inflammatory acne vulgaris - 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 - Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities Nd:YAG laser (10'64 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 imfiamed 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 Source page: https://510kreport.com/device/K090126 Methodology: https://510kreport.com/methodology