(88 days)
The AviClear Laser System is indicated for the long-term treatment of mild to severe inflammatory acne vulgaris.
The AviClear Laser System is an infrared diode laser device with a nominal wavelength of 1726 nm. Similar to other well-established infrared laser devices, the device uses a combination of the treatment spot size, beam characteristics, and tissue absorption and scattering coefficients at the output wavelength to deliver energy to tissues at depth. The wavelength of the laser energy, when combined with the pre, parallel (during energy delivery), and post cooling of epidermal and superficial dermal structures, causes selective heating of dermal tissue at different depths. The 1726 nm laser energy heats the chromophore, sebum within sebaceous glands, which results in controlled thermal injury of the sebaceous glands, the ultimate treatment target, thus reducing or eliminating sebum production and causing an improvement in acne vulgaris.
The diode laser and associated beam delivery optics, laser and electronics power supplies, control electronics, and cooling system are housed inside a console equipped with a touchscreen user interface. The laser treatment parameters are selected using the touchscreen.
The treatment handpiece has an integrated scanner for delivering treatment spot(s) in an operator-selected pattern; a temperature-controlled skincontact cooling window to provide thermal protection for the epidermis and superficial dermis and through which energy is delivered to the patient; and skin-contact pressure sensors that enable laser energy delivery when the system is in Ready mode and the footswitch is depressed.
This document describes the regulatory clearance (K230660) for the AviClear Laser System. It is a 510(k) summary, which means the manufacturer is asserting their device is substantially equivalent to a legally marketed predicate device. In this case, the predicate device is a previous version of the AviClear Laser System (K213461). The current submission (K230660) appears to be primarily for minor design modifications to the handpiece and user interface, while leveraging clinical data from the prior clearance for efficacy and safety.
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are related to the clinical study supporting the original clearance (K213461), which is then referenced to support the current substantial equivalence claim.
Here's the breakdown based on the provided text, focusing on the clinical study details:
1. A table of acceptance criteria and the reported device performance
The document primarily focuses on a single primary effectiveness objective and several secondary objectives rather than a predefined "acceptance criteria" table in the typical sense of a rigorous statistical hypothesis test with predefined alpha or beta. However, based on the primary effectiveness objective, we can construct the following:
| Acceptance Criteria (Primary Effectiveness Objective) | Reported Device Performance |
|---|---|
| Objective: Show that more than 50% of subjects enrolled were Responders who achieved Treatment Success. | Primary Endpoint (12-weeks): Results for this primary endpoint are not explicitly reported in the provided text for K230660, but are stated to have resulted in FDA 510(k) clearance for K213461, implying the criterion was met. The document states: "The study's primary effectiveness objective was to show more that than 50% of subjects enrolled were Responders who achieved Treatment Success, where Treatment Success was defined as a subject with ≥50% fewer inflammatory acne lesions with respect to baseline." |
| Long-Term Effectiveness (52-weeks): | Reported: At the 52-week post-final treatment follow-up visit, 91.5% of subjects achieved treatment success (p |
§ 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.