(87 days)
The Diode Laser Therapy Device is indicated 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. It is suitable for all skin types (Fitzpatrick skin type I-VI), including tanned skin.
The Diode Laser Therapy Devices is designed to be used in dermatological practice for stable, long term hair reduction. The principle of laser hair removal is selective photothermolysis. The wavelength of 810nm, 755, and 1064nm would be able to effectively penetrate deep into and absorbed by the target chromophore. The laser power is delivered to the treatment region via a delivery system. The proposed device includes power supply system, delivery system, control system, cooling system, laser system. The 755nm, 810nm, 1064nm handpieces with different treatment size are available for different models.
The provided text describes a 510(k) premarket notification for a Diode Laser Therapy Device. However, it explicitly states "VIII Clinical Testing: It is not applicable." Therefore, the document does not contain information about clinical studies with acceptance criteria, sample sizes, expert ground truth establishment, MRMC studies, or standalone performance for an AI/CADe device.
The information you are requesting typically applies to the clinical evaluation of AI/CADe devices, often involving extensive human reader studies and ground truthing. This document is for a laser therapy device, and its clearance process does not involve such studies for proving device performance in the same way an AI/CADe device would.
Therefore, I cannot populate the table or answer the questions related to acceptance criteria and the study that proves the device meets them based on the provided text. The document focuses on non-clinical testing (electrical safety, electromagnetic compatibility, biocompatibility) to demonstrate substantial equivalence to a predicate device.
§ 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.