(52 days)
The 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 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 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.
The Laser Treatment System includes two (2) models, NYX and Grace, the differences between them are the external shape and the numbers of the handpiece connectors, NYX is the desktop type with one handpiece connector, and Grace is vertical stand type with two handpiece connectors.
This FDA 510(k) summary describes a Laser Treatment System (Models: NYX and Grace) intended for hair removal and permanent hair reduction. The document focuses on demonstrating substantial equivalence to a predicate device (Diode Laser Treatment System, K182924) through non-clinical performance testing.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The documents do not explicitly present a table of "acceptance criteria" for clinical effectiveness in the context of hair removal/permanent hair reduction and corresponding "reported device performance." Instead, the acceptance criteria are largely implied by compliance with recognized standards for safety and the demonstration of equivalent technological characteristics to the predicate device.
The closest we get to performance criteria are the "Indications for Use":
- "The 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."
However, the provided text does not contain data or study results demonstrating that the device meets this specific performance definition (i.e., measured hair reduction at 6, 9, and 12 months). The summary only describes non-clinical performance testing for safety and software.
Table summarizing implied acceptance criteria (primarily safety and technical equivalence) and their reported fulfillment:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Safe for skin contact. | Comply with ISO 10993-1:2009 for "Surface – intact skin" with "Limited ( |
§ 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.