(99 days)
- Incision, excision, ablation, vaporization of soft tissue for general dermatology.
- 532 nm wavelength:
- removal of light ink (red, tan, purple, and orange) tatoos, "
- removal of pigmented lesions, removal of vascular lesions,
- treatment of Lentigines, treatment of Cafe-Au-Lait,
- treatment of Common Nevi,
- treatment of Seborrheic Kearotoses,
- treatment of Post Inflammatory Hyperpigmentation.
- 1064 nm wavelength:
- removal of dark ink (black, blue and brown) tattoos, -
- treatment of Nevus of Ota, -
- removal or lightening of unwanted hair, -
- treatment of Common Nevi. -
- skin resurfacing with or without adjuvant preparation --
The Fotona QX laser system is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. There is one optical cavity containing the Nd:YAG crystal. The frequency doubled KTP Nd:YAG wavelength is achieved by directing the Nd: YAG laser beam through a frequency doubling non-linear 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 articulated arm to a focusing handpiece. Both lasers are used in non-contact mode. Both laser wavelengths share a common power supply, control system, and cooling system. The internal computer can be directed to select either the Nd: YAG head or the KTP Nd: YAG laser wavelength. When the laser is first turned on the physician is able to select the desired wavelength via control panel. The Fotona QX laser system consists of: a) A high voltage power supply, which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse. b) A cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger. c) The microprocessor based controller, which regulates the functions of both lasers and allows parameter selection by the user. d) The Nd: YAG laser head. e) The frequency doubling crystal. g) The optical delivery system, interfacing the energy from the laser to the patient via an articulated arm and focusing handpiece.
The provided text does not contain information about acceptance criteria or a study that specifically proves the Fotona QX Nd:YAG/KTP Laser System meets acceptance criteria. The document is a 510(k) premarket notification for the device, which aims to demonstrate substantial equivalence to previously cleared predicate devices, rather than presenting a de novo study with specific performance metrics and acceptance criteria.
Therefore, I cannot extract the requested information. The document focuses on:
- General Information: Company, contact, device trade names, classification.
- Device Description: Technical specifications of the laser system (Nd:YAG and KTP Nd:YAG wavelengths, energy delivery, spot sizes).
- Intended Use: Clinical applications for both 1064 nm and 532 nm wavelengths (e.g., tattoo removal, pigmented lesions, hair removal, skin resurfacing, soft tissue ablation).
- Summary of Substantial Equivalence: Comparison of the Fotona QX system's design features and intended uses to three predicate devices (Spectra-VRM, Medlite C6, and Palomar Q-YAG) to argue that it raises no new questions of safety or effectiveness.
- FDA Correspondence: Letter from the FDA granting substantial equivalence.
- Indications for Use Statement: Formal list of approved clinical applications.
The document lacks information on:
- Acceptance Criteria Table: There is no table defining specific performance metrics and their acceptance thresholds.
- Reported Device Performance: No clinical study results or performance data (e.g., efficacy rates, side effect profiles, a specific measure of "success" for tattoo removal or lesion treatment) are presented.
- Sample Size and Data Provenance: No mention of test set sample sizes, country of origin, or whether any data was retrospective or prospective.
- Number and Qualifications of Experts: No experts are mentioned as establishing ground truth for any test set.
- Adjudication Method: Not applicable as no ground truth establishment is described.
- MRMC Comparative Effectiveness Study: No such study is described, nor any effect size of AI assistance.
- Standalone Performance: Not applicable as this is not an AI/algorithm-only device.
- Type of Ground Truth: No ground truth (expert consensus, pathology, outcomes data) is mentioned as being used for any study.
- Training Set Sample Size: Not applicable as this is not an AI/machine learning model where a training set would be used.
- How Training Set Ground Truth Was Established: Not applicable.
This 510(k) submission is primarily a regulatory document demonstrating similarity to existing devices, not a scientific publication detailing a new clinical study.
§ 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.