# K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.D.
- Decided: Apr 9, 2015 after 101 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: 20 generations back to K943450 (1995). 539 ancestors in all.
62 later devices descend from it; 4 cite it directly.
0 of 602 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101306: SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models M021-4AF/3, M002-2A, Fotona D.D. (2011) Summary page 5.
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece, Fotona D.D. (2014) Summary page 5.
- K113702: Fotona XP ND: Yag Laser System, Fotona D.D. (2012) Summary page 5.
- K093162: Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis, Powerlase at / Fidelis ER Iii D, HT Fid, Fotona D.D. (2010) Summary page 5.
- K090126: Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model MOO1-14F, MOO1-14F, MOO1-14F/2,, Fotona D.D. (2009) Summary page 5.
- K083889: Fotona QX ND:Yag/KTP Laser System Family, Fotona D.D. (2009) Summary page 5.
- 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 5.
- K990243: Fotona Fidelis ER:Yag Laser System & Accessories, Fotona D.D. (1999) Summary page 5.

## Most influential descendants
- K153671: Family of CoolGlide Aesthetic Lasers (2016), 32 descendants of its own
- K170626: Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece (2017), 24 descendants of its own
- K172193: Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules (2018), 22 descendants of its own
- K182088: XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro (2018), 20 descendants of its own
- K222064: The Alma Soprano Titanium (2022), 14 descendants of its own

## Indications for use
**Dynamis Er:YAG laser (2940 nm wavelength) The Fotona Dynamis Er:YAG laser is intended for surgical incision/excision, cutting ablation, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands. · Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and soft tissue resurfacing; · ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia; · Oral/Maxillofacial Indications: Oral and glossal lesions; · Ophtalmology Indications: Soft tissue surrounding the eye ; · Intra-oral soft tissue incision, excision, ablation, coagulation; · 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; · 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; · Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy; · The Fotona F-22 Handpiece is intended for: - In fractionated mode: Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece; - In non-fractionated mode: 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; · The Fotona FS-01 Handpiece is intended for: - Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece; **Dynamis Nd:YAG laser (1064 nm wavelength): The Fotona Dynamis Nd:YAG laser is intended for incision, ablation,vaporization coagulation and hemostasis of vascular lesions and soft tissue in various dermatological and surgical areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI. · 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, fibroma removal, frenectomy and frenotomy; · Treatment of Aphthous Ulcers; · Excision and Vaporization of Herpex Simplex I and II; · Laser assisted uvulopaletoplasty (LAUP); · 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. Permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treament regime; · 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; · Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: o Matrixectomy o Radical nail excision o Periungual and subungual warts o Plantar warts o Neuromas o Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.) · Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities.

Source page: https://510kreport.com/device/K143723
Methodology: https://510kreport.com/methodology