(227 days)
The enlighten 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 laser system is indicated for 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 laser system is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.
The enlighten laser system is a multi-wavelength, pulsed laser system designed for tattoo removal. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm) and pulse widths (750 ps and 2 ns, nominal). 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. The system is operated using 110 V mains AC power.
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 a detachable tip that determines the spot size of the laser beam on the treatment surface. Multiple tips are provided to vary the spot size as desired for treatment. The beam of a low-power red diode laser is also transmitted through the arm to provide an aiming beam.
Acceptance Criteria and Device Performance Study for the Enlighten Laser System
This document outlines the acceptance criteria and a detailed description of the study conducted to demonstrate the performance of the enlighten Laser System for tattoo removal.
1. Acceptance Criteria and Reported Device Performance
The core acceptance criteria for the enlighten Laser System, as demonstrated by the clinical study, revolves around the efficacy of tattoo clearing and safety.
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implicit from Study Design) | Reported Device Performance |
|---|---|---|---|
| Efficacy (Overall) | Mean improvement in tattoo clearing (Blinded Reviewer Global Assessment) | Statistically significant and clinically meaningful improvement in tattoo clearing compared to baseline, and demonstration of substantial equivalence or superiority to a comparator device. | Overall Mean Improvement: 2.54 (95% CI: 2.13–2.94) for the investigational device vs. 2.17 (95% CI: 1.77–2.57) for the comparator device at 6 weeks post-final treatment. |
| Mean Difference: 0.37 (95% CI: 0.20–0.53) indicating statistically significant (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.