SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro

Fotona D.D.

Country / region:Slovenia (SI)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Slovenia (SI)

Product code

GEX
21 CFR 878.4810

Predicate devices

8

Cited as predicate

5

Device details

FDA 510(k) registration fields

K number
K143723
Device name
SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro
Country / region
Slovenia(SI)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2014-12-29
Decision date
2015-04-09
Submission type
Traditional
Technology type
Er:YAG(AI inferred)
Clinical applications
Surgical cuttingSkin resurfacing
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

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;

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 incision, 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 Herpes 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. Per

Intended Use

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.

Device Description

The Fotona Dynamis Pro Laser System Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. The laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The unit combines two flashlamp-pumped laser sources in one housing, with optical cavities containing the Er:YAG and Nd:YAG crystals. A red diode aiming beam (650 nm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical manual or scanner hand piece (in the case of the Er:YAG laser), or through an optical fiber delivery system to an optical manual or scanner handpiece (in the case of the Nd:YAG laser). Optionally, the Nd:YAG therapeutic and aiming laser beams can be guided through a fiber having a connector on the proximal end and a bare fiber on the distal end. Fotona's power supply Variable Square Pulse (VSP) Technology, integrated into the laser system, allows control of the laser energy and the laser pulse duration. The user activates laser emission by means of a footswitch. The Fotona Dynamis Pro Family is designed to operate in single wavelength (Nd:YAG or Er:YAG) configurations (models) and dual wavelength (Nd:YAG and Er:YAG) configurations (models).

Summary parsed at:2026-06-01 06:10:46 UTC

Predicate devices

8

K143723 references 8 predicate/reference devices

Cited as predicate

5

5 submissions cite K143723 as a predicate