(159 days)
Nd: YAG laser (1064 nm wavelength) in dermatology and other surgical areas:
- Surgical incison, excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartilage, mucous membrane, lymph vessels and nodes, organs and glands. It is further indicated for 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
- 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, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins
- Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities
Nd:YAG laser (1064 nm wavelength) in dentistry:
- Excisional and incisional biopsies
- Excision and vaporization of herpes simplex I and II
- Exposure of unerupted teeth
- Fibroma removal
- Frenectomy and frenotomy -
- Gingival troughing for crown impressions -
- -Gingivectomy
- Gingivoplasty -
- Gingival incision and excision -
- Hemostasis -
- Implant recovery -
- Incision and drainage of abscess -
- Laser assisted uvulopaletoplasty (LAUP) -
- Operculectomy -
- Oral papillectomies -
- Pulpotomy and pulpotomy as an adjunct to root canal therapy -
- Reduction of denture hyperplasia -
- Reduction of gingival hypertrophy -
- Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy
- Removal of post-surgical granulations -
- Soft tissue crown lengthening
- Sulcular debridement or soft tissue curettage (removal of diseased or imflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility)
- Tissue retraction for impression
- Treatment of aphtous ulcers
- Vestibuloplasty
The Fotona XP Laser System Family is based on the Nd: YAG (1064 nm) laser technology. There is one optical cavity containing the Nd: YAG crystal. The Nd: YAG laser is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path, using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by an optical fiber delivery system to an optical handpiece. Optionally, the laser beams can be guided through fiber having SMA905 connector on the proximal end bare fiber on distal end. The user activates laser emission by means of a footswitch.
The Nd:YAG (1064 nm) laser can be operated with variable pulse durations in the range of 0.1-50 msec, with repetition rates up to 100 Hz and laser pulse energies up to 10 J. Depending on the type of treatment, the user can choose between a PULSE mode user interface, and a OCW (Ouasi-Continuous Wave) mode user interface. The laser operation is the same for both modes, the difference is only in the laser parameters that can be directly selected from the keyboard.
In the PULSE user interface mode the user can directly select the handpiece treatment spot size, laser fluence, pulse duration and pulse repetition rate. This mode is intended primarily for treatments at relatively small repetition rates, or in individual pulses, and at relatively high pulse energies. In this mode, a major expected treatment effect is the selective photothermolysis of target chromophores in soft tissue. For this reason it is more effective and safer that the energy is delivered to target chromophores in a relatively short time, in order not to cause damage to the surrounding tissue. Typically, the illuminated areas, or spotsizes are larger than 1 mm. A spotsize is determined by choosing and adjusting the handpiece. In this mode, the relevant and sufficient treatment parameters that have been accepted by the medical community are laser pulse energy, laser pulse fluence (energy over the spot-size area), pulse duration and pulse repetition rate.
In the QCW user interface mode the user can directly select the laser pulse repetition rate, pulse width and the average laser power. This mode is intended primarily for treatments at relatively high repetition rates and small pulse energies. In this mode, a major expected treatment effect is incision, excision and coagulation of tissue via heating of the tissue in close contact with the fiber delivery of a known diameter (typically smaller than 1.0 mm), and over a time typically longer than 0.5 sec. For this reason, in this mode, average power, repetition rate (frequency) and pulse-width are the relevant and sufficient treatment parameters, accepted by the medical community, for performing various dental or surgical procedures.
This document is a 510(k) Pre-market Notification for the Fotona XP Nd:YAG Laser System Family. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a study proving the device meets specific performance acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria and a study to prove devices meet these criteria is not contained within this document.
The document primarily provides:
- Device Description: Details the technical specifications and operational modes (PULSE and QCW) of the Fotona XP Laser System Family.
- Indications for Use: Lists the intended medical applications for the laser system in dermatology, other surgical areas, and dentistry.
- Statement of Substantial Equivalence: Compares the Fotona XP system to several legally marketed predicate devices, asserting comparability in terms of indications, technical specifications, and design. The FDA's letter of clearance confirms this substantial equivalence.
Since this submission is a 510(k) for substantial equivalence, it relies on the safety and effectiveness of the predicate devices. It does not contain an independent clinical study with defined acceptance criteria for the Fotona XP Nd:YAG Laser System Family itself.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement as this information is not provided in the supplied 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.