(178 days)
The Diode Laser Treatment System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The Diode Laser Treatment System consists of the main unit and a hand piece. The system uses a diode laser as an active medium placed in an optical cavity to produce amplified beam at the wavelength of 808 nm. A microprocessor is used to control electronics for the front panel. A self-contained water cooling system is built into the power supply unit. The device provides 36 working modes, which are six modes for men and six modes for women. The men or women mode includes face, armpit, arm, body, bikini, leg mode respectively for different treatment part. The diode laser operates in a pulsed mode with a fixed pulse width and fixed pulse duration of the pulse train for each mode. The number of pulses can be adjusted within the preset range.
This document describes a 510(k) premarket notification for the Weifang KM Electronics Co., Ltd. Diode Laser Treatment System. The notification aims to demonstrate substantial equivalence to legally marketed predicate devices for hair removal and permanent hair reduction.
Based on the provided text, a clinical study proving the device meets specific performance-based acceptance criteria for hair reduction was not described. The document focuses on demonstrating substantial equivalence primarily through technological characteristics and non-clinical performance data (biocompatibility, electrical safety, EMC, and laser safety).
Here's an analysis based on your requested information:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state performance-based acceptance criteria for hair reduction (e.g., a percentage of hair reduction required) or reported device performance in terms of clinical efficacy. Instead, it defines "Permanent hair reduction" as "the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime." This is a definition rather than an acceptance criterion with a specific threshold.
The document does include acceptance criteria and reported performance for non-clinical testing:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| ISO 10993-1:2009 for "Surface – Mucosal Membrane" with contact duration " |
§ 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.