(90 days)
The ProLite™ Pulsed Light System, equipped with the HR handpiece and 600 nanometer filter, is intended for the removal of unwanted hair in all Fitzpatrick skin types.
The ProLite™ Pulsed Light System, equipped with the SR handpiece and 550 or 580 nanometer filters, is intended for the treatment of benign pigmented lesions and the removal of tattoos, the treatment of vascular lesions, and the treatment of shallow facial veins, telangiectasia, facial hemangiomas, and rosacea vascular lesions
The 550 nanometer filter may be more efficient for Types I and II skin. The 580 nanometer filter may be more efficient for Types III and IV skin.
The ProLite™ Pulsed Light System uses a Xenon Flash Lamp which is filtered to specified wavelengths for its intended uses. The System consists of a cabinet with power supply, a distilled water cooling system, the microcontroller, an umbilical which attaches to a handpiece which houses the selected filter.
The provided text explicitly states, "Performance Data: None required." It clarifies that "The claim of substantial equivalence is based the fact that the ProLite™ Pulsed Light System described in this premarket notification is the same as described in several previous premarket notifications. No changes in specifications, performance characteristics, or indications for use are proposed."
Therefore, based on the input text:
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A table of acceptance criteria and the reported device performance: Not provided. The submission claims no performance data was required because the device is "substantially equivalent to itself."
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no performance data or test set was reported.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no ground truth was established for a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set or adjudication was performed.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a pulsed light system, not an AI-assisted diagnostic tool, and no comparative effectiveness study was reported.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical system, not an algorithm, and no standalone performance study was reported.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth was established or used for performance evaluation.
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The sample size for the training set: Not applicable, as no training set was mentioned or used for device development or evaluation.
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How the ground truth for the training set was established: Not applicable, as no training set or its ground truth was established.
§ 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.