(90 days)
Er: Y AG laser (2940 nm wavelength):
The Dynamis Er: Y AG laser is intended for surgical incision, 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;
- Ophtalmology Indications: Soft tissue surrounding the eye ;
- Intra-oral soft tissue incision, excision, ablation, coagulation;
- General Surgery Indications: Surgical incision, 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 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;
Nd:YAG laser (1064 nm wavelength):
The Dynamis Nd:YAG laser is intended for incision, ablation, vaporization and hemostasis of vascular lesions and soft tissue in various dermatological areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI.
- Surgical incison, excision, vaporization, ablation, coagulation and hemostasis of soft tissue. All soft tissue is included, strated 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 thair 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 varicosities.
The Dynamis Pro 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.
The 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).
This document does not contain information about acceptance criteria and device performance in the context of a study for an AI/ML powered device. This is a 510(k) premarket notification for a laser surgical instrument, which is a hardware device. The provided text outlines the device description, indications for use, and a comparison to a predicate device to establish substantial equivalence.
Specifically, it details:
- Device Name: Dynamis Pro Family
- Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
- Regulatory Class: Class II
- Product Code: GEX
- Predicate Device: Fotona Dynamis Pro Family (K143723)
- Key components: Er: YAG (2940 nm) and Nd: YAG (1064 nm) laser technology.
- Substantial Equivalence Discussion: The document states that the Dynamis Pro Family has the same technological and design characteristics as the predicate device (K143723) and that the output characteristics for the intended use are the same. The differences noted are additional optical manual and scanner Nd:YAG and Er:YAG handpieces and additional indications for soft tissue resurfacing and treatment of wrinkles with specific scanners.
The "TESTING" section lists various engineering and safety standards (e.g., EN 60601-1, EN 60601-2-22, EN ISO 14971, EN 62304) that the device has been evaluated against. These are general standards for medical electrical equipment, laser safety, biological evaluation, risk management, and software life-cycle processes, applied to ensure the device's safety and effectiveness.
However, none of the information provided relates to:
- Acceptance criteria and reported device performance specific to an AI/ML algorithm.
- Sample size used for a test set in an AI/ML context.
- Number of experts used to establish ground truth for an AI/ML test set.
- Adjudication method for an AI/ML test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size of human improvement with AI.
- Standalone (algorithm-only) performance.
- Type of ground truth (expert consensus, pathology, outcomes data) for an AI/ML model.
- Sample size for the training set of an AI/ML model.
- How ground truth for the training set was established for an AI/ML model.
Therefore, I cannot provide the requested information based on the given text, as the provided document pertains to a traditional laser medical device, not an AI/ML-powered device.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.