(49 days)
The Aesthera Photopneumatic™ (PPx™) System is intended for:
- The treatment of benign vascular and pigmented lesions: .
- Permanent hair reduction; .
- The treatment of mild to moderate acne, including pustular acne, comedonal acne, . and mild to moderate inflammatory acne (acne vulgaris).
The Aesthera Photopneumatic™ (PPx™) System is intended for use on all skin types (Fitzpatrick skin types I-VI).
The Aesthera Photopneumatic™ (PPx™) System is comprised of the following main components:
- . Main console
- PPx™ Treatment Handpiece .
- Optional coolant accessory cryogenic, water, or air spray for cooling the handpiece . tip; and
- . Treatment Footswitch.
The Aesthera Photopneumatic™ (PPx™) System (with treatment handpiece) is a portable tabletop system used to deliver intense pulsed light to the patient treatment site via a delivery handpiece utilizing Photopneumatic technology. Intense pulsed light is emitted through the IntelliTip™ only when the tip is sealed against the selected patient treatment All emitted light is contained within the IntelliTip™ during treatment. site. The handpiece is uniquely designed to promote increased ergonomics with all user interface and controls located on the handpiece.
The provided text is a 510(k) summary for the Aesthera Photopneumatic™ (PPx™) System. It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, it does not contain detailed information about specific acceptance criteria, a formal study design with performance metrics, sample sizes for test sets, data provenance, expert qualifications, or adjudication methods typically found in clinical trial reports or detailed performance studies.
The document states: "Clinical data demonstrating the safety and effectiveness of the Aesthera Photopneumatic™ (PPx™) System for the treatment of mild to severe acne, including pustular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris) was provided." However, it does not elaborate on the specifics of this clinical data.
Therefore,Based on the provided text, I cannot complete the requested tables and information. The document is a 510(k) summary focused on substantial equivalence, and it lacks the detailed performance study information required to answer your questions.
§ 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.