(274 days)
Intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic, laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonarythoracic surgery, podiatry and urology for surgical and aesthetic applications.
For intended use in Dermatology for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, rosacea, poikiloderma of civatte, and treatment of benign cutaneous lesions, such as warts, scars and striae. Also intended for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
For intended use on all skin types (Fitzpatrick I-VI), including tanned skin.
For intended use in Podiatry for the ablation, vaporization, incision, excision, and coagulation of soft tissue, including Matrixectomy, Periungual and subungual warts, Plantar warts, Radical nail excision, Neuromas.
For intended use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.).
The FREEDOM Laser System consists of a self-contained console, an optical fiber delivery system and a footswitch. The system console is the FREEDOM Laser System and contains the Nd: YAG optical system, laser system control, fiber delivery system with handpiece, system control module with an embedded processor, and power supply module. The main console also includes a key switch used to turn the power on and off, an emergency stop push button that quickly de-energizes the system in emergency situations, and the LCD display.
The provided document, a 510(k) summary for the Lutronic Corporation FREEDOM Laser System, explicitly states "Performance Data None presented." Therefore, based solely on the provided text, there is no study described that proves the device meets acceptance criteria, nor are there any acceptance criteria defined within this document.
Consequently, I cannot fill out the requested table or answer the specific questions related to a study's methodology, sample sizes, expert involvement, or comparative effectiveness.
Without any performance data or acceptance criteria detailed in the submission, the table would be empty for the "Acceptance Criteria" and "Reported Device Performance" columns. All other points requesting information about a study would also be unanswerable from the provided text.
§ 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.