(249 days)
The enlighten III laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064 nm:
The 1064 nm wavelength of the enlighten III laser system is indicated for:
- treatment of benign pigmented lesions on patients with all skin types (Fitzpatrick I-VI)
- tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI)
532 nm:
The 532 nm wavelength of the enlighten III laser system is indicated for:
- treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III
- tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III
670 nm:
The 670 nm wavelength of the enlighten III laser system is indicated for treatment of benign pigments with Fitzpatrick skin types I-III.
The enlighten III laser system is a multi-wavelength, pulsed laser system. A key feature of the device is its ability to produce multiple laser wavelengths and pulse widths (1064 and 532 nm: 750 ps and 2 ns; 670 nm: 660 ps).
The laser, power supplies, and control electronics are housed inside a console equipped with a touchscreen control panel. The laser treatment parameters are selected using the control panel. Laser emission is activated by depressing a footswitch. An articulated arm with rotational mirror knuckles delivers the laser beam from a laser head inside the console to a handpiece. The handpiece is equipped with an optical zoom assembly that determines the spot size of the laser beam on the treatment surface. The beam of a low-power diode laser is also transmitted through the arm to provide an aiming beam.
Here's an analysis of the acceptance criteria and study proving the device's performance, based on the provided text:
Device: enlighten III Laser System
Indications for Use (670 nm wavelength): Treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a formal "acceptance criteria" table with pre-defined numerical targets. Instead, the study aims to demonstrate safety and efficacy, implicitly establishing that a certain level of improvement and safety is acceptable for market clearance. Based on the study results, the implied acceptance criteria for efficacy appears to be achieving statistically significant lightening (>50% improvement) and high patient satisfaction for the treatment of benign pigmented lesions. Safety is assessed by the absence of serious adverse events and good tolerability.
| Feature / Criteria | Implied Acceptance Standard (from study results) | Reported Device Performance (670 nm wavelength) |
|---|---|---|
| Efficacy | ||
| >50% BPL Lightening (Cohort 1) | Achieve statistically significant improvement. | Observed in 66% of treated BPL areas (median improvement score of 2.00, statistically significant: p50% BPL Lightening (Cohort 2) |
§ 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.