(52 days)
The LuxIR is intended for the photocoagulation of soft tissue in dermatologic applications including but not limited to the treatment of warts and tattoos.
The Palomar LuxIR Handpiece delivers infrared light with a wavelength of 850-1350 & 1700-2500 nm. The complete system consists of a power source, chiller, a footswitch, and a handpiece connected to the power unit with an umbilical. In standard use, the handpiece is held in firm contact with the skin. The handpiece tip is water-cooled to provide active skin cooling. System parameters and other system features are controlled from the user interface panel on top of the power unit.
The provided text does NOT include details about acceptance criteria or a study proving device performance in the way requested. It is a 510(k) summary for a medical device (Palomar LuxIR Handpiece) seeking clearance based on substantial equivalence to predicate devices. This type of submission typically focuses on comparing the new device's specifications and intended use to existing, legally marketed devices, rather than presenting a performance study against specific acceptance criteria.
Therefore, for aspects like:
- Table of acceptance criteria and reported device performance
- Sample sizes for test or training sets
- Data provenance
- Number and qualifications of experts
- Adjudication methods
- MRMC comparative effectiveness studies
- Standalone performance
- Type of ground truth used
- How ground truth for training was established
The document contains no information.
The document states:
- Intended Use: The Palomar LuxIR Handpiece is intended for the photocoagulation of soft tissue in dermatologic applications including but not limited to the treatment of warts and tattoos.
- Performance Data: The summary mentions "Performance Data" as a header but provides no actual data, only a conclusion.
- Conclusion: "The differences in the specifications of the Palomar LuxIR Handpiece and the predicate device do not result in different performance or raise new questions of safety or efficacy. Based on the foregoing, the Palomar LuxIR Handpiece is substantially equivalent to the legallymarketed claimed predicate device."
This indicates that the clearance was based on demonstrating equivalence, not on a new clinical performance study establishing specific acceptance criteria for efficacy or safety.
§ 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.