(58 days)
The Diode laser device is intended for use in dermatology procedures requiring coagulation. The indications for use for the Trio-Wavelength Handpiece include: The Fast Hair Removal (FHR) Mode is intended for temporary hair reduction. The HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the HR mode include: Benign vascular and vascular dependent lesions.
The 810nm wavelength handpiece is intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and FHR Modes).
The Diode Laser device includes two handles with different laser band characteristics. One handle contains a single-band 808nm semiconductor laser, and the other handle contains a three-band (755nm/808nm/1064nm) semiconductor laser. The semiconductor lasers of the two handles are powered by the laser power supply in the host to emit laser of corresponding wavelength.
Working principle of semiconductor laser
Semiconductor laser uses semiconductor materials of different doping types as laser working substance, uses natural cleavage surface to form resonant cavity for laser oscillation and amplification, and adds forward voltage to PN junction area of semiconductor laser to form particle number inversion of non-equilibrium carrier between conduction band and valence band of semiconductor substance. When a large number of electrons and holes in particle number inversion state are recombined, excess energy will be released, and these energies will be expressed in the form of photons, that is, laser is formed. Due to resonance amplification of cleavage surface resonant cavity, the stimulated feedback is amplified, so that laser can be directionally emitted and output from semiconductor laser.
The Diode laser device consists of a main unit, a handheld, a foot switch and a power cord.
Mode Description
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Trio FHR Mode
The Diode Laser device Trio-Wavelength module with FHR mode is intended for temporary hair reduction.
In this mode, there is a set of parameter setting ranges. The specific parameter ranges are as follows: Frequency is 10 Hz and energy fluence is 2-8J/cm2. The operator can adjust the parameters within this range according to the actual situation. -
Trio HR Mode
The Diode Laser device Trio-Wavelength module with HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the HR mode include: Benign vascular and vascular dependent lesions.
In this mode, there is a set of parameter setting ranges. The specific parameter ranges are as follows: Frequency is 1-10 Hz and energy fluence is 2-60J/cm2. The operator can adjust the parameters within this range according to the actual situation. -
810nm wavelength
The 810nm wavelength handpiece is intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI)including tanned skin. (HR, and FHR Modes)
HR Mode: In this mode, there is a set of parameter setting ranges. The specific parameter ranges are as follows: Frequency is 1-10 Hz and energy fluence is 2-60J/cm2. The operator can adjust the parameters within this range according to the actual situation.
FHR Mode: In this mode, there is a set of parameter setting ranges. The specific parameter ranges are as follows: Frequency is 10 Hz and energy fluence is 2-8J/cm2. The operator can adjust the parameters within this range according to the actual situation.
The FHR Mode of the two handpiece (810nm& Trio-Wavelength) is the fast hair removal mode. This mode means a quick option for pulse frequency. In the FHR mode, the frequency is fixed at 10Hz and cannot be adjusted. The FHR mode of the 810nm handpiece is used for permanent reduction in hair regrowth defined as a long term, while the FHR mode of the Trio -wavelength handpiece is used for temporary hair reduction.
The HR mode of the two handpiece (810nm& Trio-Wavelength) is designed to differentiate from the FHR mode in terms of parameters. The HR mode covers all pulse frequency ranges (frequency: 1 - 10 Hz), and the pulse frequency can be adjusted. The HR mode of the 810 nm handpiece is used for permanent reduction in hair regrowth defined as a long term, while the FHR mode of the Trio -wavelength handpiece is used for benign vascular and vascular dependent lesions.
- Operation Differences:
In terms of user operation, the software has two operation modes: HR mode and FHR mode. After startup, there will be a selection interface for these two modes. Users can select different devices to enter different interfaces. In the HR mode interface, can adjust the frequency and energy fluence through the up and down buttons. In the FHR mode interface, the frequency cannot be adjusted, and only the energy fluence can be adjusted through the up and down buttons. Other operations are the same for both modes.
The provided FDA 510(k) clearance letter for the Diode laser device (RF3120-BI) does not contain information about a study proving the device meets acceptance criteria related to AI or algorithm performance.
The document details the device's technical specifications, its intended use (dermatology procedures, hair reduction, benign vascular/vascular-dependent lesions), and comparisons to predicate devices in terms of technical parameters like spot size, energy fluence, and pulse frequency. It also lists several non-clinical tests the device has undergone to ensure electrical safety, laser safety, and biological compatibility (skin sensitization, irritation, cytotoxicity).
Crucially, the clearance letter explicitly states: "The clinical study is not applicable." This indicates that the regulatory pathway for this specific device did not require a clinical study demonstrating its performance in treating patients, nor does it mention any AI or algorithmic components that would necessitate such a study or associated performance metrics like sensitivity, specificity, or AUC.
Therefore, I cannot fulfill your request for information related to "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI or algorithmic performance, as the provided document does not disclose any such study or AI component.
Based on the provided text, the device's acceptance criteria are based on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with relevant safety and performance standards (non-clinical tests), rather than clinical efficacy studies or AI performance metrics.
If the device did incorporate AI, the FDA clearance letter would typically describe a study to validate its performance according to specific acceptance criteria. Since that information is absent, it suggests the device does not rely on AI for its claimed indications.
§ 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.