# K101306: SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models M021-4AF/3, M002-2A

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.D.
- Decided: Jul 1, 2011 after 417 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: 11 generations back to K943450 (1995). 149 ancestors in all.
78 later devices descend from it; 6 cite it directly.
0 of 228 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021548: Fotona Dualis ND:Yag/ER:Yag Laser System, Fotona D.D. (2002) Summary page 1.
- 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 1.
- 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 1.
- 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 1.

## Most influential descendants
- 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
- K170626: Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece (2017), 24 descendants of its own

## Indications for use
Dynarnis Er:YAG laser (2940 un wavelength) - 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; - Ophitalmology Indications: Soft tissue surrounding the eye; - Gynecology Indications: Herpes simplex, endometrial adhesion, GIN (Cervical intraepithelial neoplasia), cysts, condiloma; - 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; Dynamis Nd:YAG laser (1064 unm wavelength): - 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; - 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 1-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, hernaongiomae, warts, telangiectasiae, rosacca, venuis lake, leg veins and spider veins; - Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities.

Source page: https://510kreport.com/device/K101306
Methodology: https://510kreport.com/methodology