# K213267: Dynamis Pro Family

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.O.O.
- Decided: Sep 8, 2022 after 343 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: 24 generations back to K943450 (1995). 568 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 571 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202985: LightWalker Laser System Family, Fotona D.O.O. (2021) Summary page 5.
- K182088: XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro, Fotona D.O.O. (2018) Summary page 5.

## Most influential descendants
- K252723: Dynamis Pro Family (2026), 0 descendants of its own
- K223540: AvalancheLase Family (2023), 0 descendants of its own

## Indications for use
Er:YAG laser (2940 nm wavelength): The 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; - Soft tissue resurfacing with S22 and S22-T scanner; - ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia; - Oral/Maxillofacial Indications: Oral and glossal lesions; - Uvulopalatoplasty by laser resurfacing - 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 and X-Restart Handpieces are intended for: - Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece; Nd:YAG laser (1064 nm wavelength): The 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 - VL. - 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-V], 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 wrinkles with S11 scanner; - 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: - Matrixectomy - Radical nail excision - Periungual and subungual warts - Plantar warts - Neuromas - 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. Nd:YAG laser (1064 nm wavelength) therapy: - Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle.

Source page: https://510kreport.com/device/K213267
Methodology: https://510kreport.com/methodology