(90 days)
The Device is indicated for hair removal and permanent hair reduction in dermatology and plastic surgery procedures.
The F1 Diode Laser System delivers a pulsed infrared laser light at a wavelength of 810 nanometers. The laser consists of several interconnected sections: The cabinet which houses the laser diode, the power supply, the PC-104, and the microcontroller, the umbilical which houses the fiber optics delivery system, and the handpiece and the external TE chiller.
This submission is a 510(k) premarket notification for the F1 Diode Laser System. The provided documents establish substantial equivalence to predicate devices based on intended use and technological characteristics. However, they do not contain information about specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any details related to AI or MRMC studies.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about the studies as such information is not present in the provided text.
The closest information available is the claim that:
- "The device, as designed, is as safe and effective as the predicate devices, and the device is substantially equivalent to the referenced predicate devices."
- "The differences between the F1 Diode Laser System and the predicate devices cited do not raise any different questions regarding safety and effectiveness."
This indicates a qualitative assessment of equivalence rather than a quantitative study with defined acceptance criteria and performance metrics.
§ 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.