(28 days)
The Serenity Pro PSF™ System is an accessory for a compatible leqally marketed Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface, just prior to the administration of the treatment beam through it.
The Serenity Pro PSF™ System is a device which has the ability to produce a vacuum at a level of 400-700 mbar. Suction can be delivered through its handpiece, which has a sapphire window at its distal end, to be positioned over the skin for laser or IPL treatment. When the PSF system is activated, the negative pressure results in the flattening of the skin of the treatment site. During the time duration of suction, the treatment beam of the laser or IPL is administered through the sapphire window of the handpiece, which is transparent and thermally conductive. The resultant tight mechanical contact produced by the PSF expels blood from the treatment site which enhances the light penetration of the laser or IPL in tissue as well as the removal of its heat from the skin. This can reduce the possibility of post treatment ervthema.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance in the format requested. The document is a 510(k) summary for the Serenity Pro PSF™ System, which describes the device, its intended use, and its substantial equivalence to a predicate device for FDA clearance. It does not detail specific performance metrics, clinical study design, or results in the way you've outlined.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text.
§ 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.