Fotona XS Dynamis
Er:YAG Resurfacing · Er:YAG 2940nm compact
Technology: Nd:YAG Laser
Classification & configurations
Category group: Resurfacing & pigment (ablative, fractional, picosecond, vascular)
At a glance
- New price
- Not published
- Used asking price
- $30k–$50kSource not documented
- FDA status
- Supplies & recurring costs
- Supply details not yet documented.
Sources and verified data on file
Data on file
- Recurring consumables
- Not verified
- Used asking prices
- Not verified
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Figures are reference points, not current offers. Used asking prices are not completed-sale values.
Read FDA-cleared indicationsExact wording from 2 FDA records
K101306 (Fotona D.D., 2011)
Statement K/Ago13 2 5 10(k) Number (if known): Fotona Dynainis Er:YAG/Nd:YAG Laser System Family 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.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K143723 (Fotona D.D., 2015)
**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.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: August 6, 2026 · How we verify
No new-equipment price range is published for this model. Ask the seller for a dated, itemized quote covering configuration, training and service.
Axis runs $0–$50k. Reference figures, not current offers. Used asking prices are not completed-sale values.
Not verified
We hold no per-treatment consumable price for this device from a dated source. Ask the seller for a written per-treatment cost.
Price sourcesSources, dates and configurations
Key factsCompany, specifications and verification dates
| Manufacturer | Fotona |
|---|---|
| Company | Owner: Vitruvian Partners LLP (London private equity); AGIC Capital retains a minority stake (private equity owned, since 2021) · Distribution: hybrid (direct + distributor) |
| Parent company | Fotona |
| Brand owner | Fotona |
| Built by (OEM) | Fotona d.o.o. |
| Category | Er:YAG Resurfacing |
| Technology | Er:YAG 2940nm compact |
| FDA status | FDA Cleared |
| 510(k) citation | K101306, K143723 |
| New price range | Not published |
| Used asking range | $30k–$50k |
| Consumables | Not published |
| Launch year | 2010 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
Erbium-only Dynamis variant
FDA & regulatory detailClearance timeline, authorization route and citation notes
FDA-cleared indications (verbatim)
K101306 (Fotona D.D., 2011)
Statement K/Ago13 2 5 10(k) Number (if known): Fotona Dynainis Er:YAG/Nd:YAG Laser System Family 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.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K143723 (Fotona D.D., 2015)
**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.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
Nd:YAG — Er:YAG 2940nm compact
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: Fotona
Legal manufacturer: Fotona d.o.o. (Slovenia)
Applicant on the FDA record
Fotona D.D.The applicant named on the FDA record can differ from the brand shown on the device.
Regulatory data comes from public FDA records and may lag recent updates. Confirm the applicable status and documentation before purchase.
Treatment & running costs
Treatments
Sessions & timing
No treatment schedule documented yet.
What practices charge
No sourced treatment price on file.
Supplies & recurring costs
Consumable costs are not documented yet.
Annual service & support
No annual service cost documented yet.
Payback calculatorModel your own volume, labor and service costs
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History4 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
August 5, 2026
FDA status
Unknown → Cleared
Source: Catalog update
August 5, 2026
FDA indication
Er:YAG + Nd:YAG multi-application (resurfacing, hair, vascular)
Source: Catalog update
August 5, 2026
FDA K-numbers
Source: Catalog update
August 1, 2026
Record created
Added to The Aesthetic Index — August 2026
Source: The Aesthetic Index editorial
Cite this data: The Aesthetic Index, "Fotona XS Dynamis — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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