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510(k) Data Aggregation
(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<0.001) greater clearing for the investigational device. |
| Efficacy (Pulse Duration) | Mean improvement with ps pulse durations only | Clinically and statistically significant mean improvement. | Mean Improvement: 3.2 (95% CI: 2.54 – 3.86, p<0.001) for ps pulses only. Difference vs. Comparator: 0.7 (95% CI: 0.22 - 1.18, p=0.01) – greatest difference. |
| Mean improvement with combined ps and ns pulse durations | Clinically and statistically significant mean improvement. | Mean Improvement: 2.77 (95% CI: 2.23 - 3.32, p<0.001) for combined ps and ns pulses. Difference vs. Comparator: 0.46 (95% CI: 0.10 – 0.81, p=0.015). | |
| Mean improvement with ns pulse durations only | Clinically and statistically significant mean improvement. | Mean Improvement: 2.3 (95% CI: 1.91 - 2.69, p<0.001) for ns pulses only. Difference vs. Comparator: 0.26 (95% CI: 0.05 - 0.47, p=0.018). | |
| Efficacy (Wavelength) | Mean improvement with 532 nm wavelength | Clinically and statistically significant mean improvement, consistent with overall study population. | Mean Improvement: 2.6 (95% CI: 1.91 - 3.29, p<0.001) for 532 nm wavelength. Consistent with overall study population. |
| Mean improvement with 1064 nm wavelength | Clinically and statistically significant mean improvement, consistent with overall study population. | Mean Improvement: 2.53 (95% CI: 2.21 - 2.85, p<0.001) for 1064 nm wavelength. Consistent with overall study population. | |
| Efficacy (Skin Type) | Mean improvement for Fitzpatrick Skin Type I-III | Clinically and statistically significant mean improvement, consistent with overall study population. | Mean Improvement: Consistent with total study population in both investigational and comparator arms. (Specific numerical value for I-III not explicitly stated, but stated as "consistent"). |
| Mean improvement for Fitzpatrick Skin Type IV-VI | Clinically and statistically significant mean improvement. | Mean Improvement: 2.33 (95% CI: 1.55 – 3.12, p<0.001) for FST IV-VI. Slightly lower than overall study mean, but comparator arm also lower by a similar margin. | |
| Safety | Incidence and severity of adverse events | Tolerable treatments, equivalent adverse event profiles to comparator device, and no serious adverse events. | Pain Scores: Similar with both devices (mean 4.1 vs. 4.4 on 0-9 scale). Common AEs: Expected erythema, edema, and pin-point bleeding in both arms. Serious AEs: No serious adverse events reported. Subgroup AEs: Equivalent adverse event profiles for all subgroups; no significant differences in incidence/severity. |
| Additional Data | Mean tattoo clearance for unilateral picosecond-only treatments (12 weeks post-final) | Consistent with 6-week picosecond-only data from the main study. | Mean Clearance: 3.4 for 19 additional unilateral picosecond-only treatments at 12 weeks post-final treatment, consistent with the 3.2 clearance rating from the 6-week data. AEs: edema and erythema consistent with main study; no unexpected or serious adverse events. |
| Substantial Equivalence | Overall comparison to predicate devices | Demonstrate substantial equivalence to predicate devices in terms of indications for use, technical specifications, operating performance features, and general design, with equivalent or superior safety and effectiveness. | The study concluded that the enlighten laser system is substantially equivalent to the predicate devices for the requested indication based on safe and effective tattoo removal, with the investigational device showing statistically significant (p<0.001) greater clearing than the comparator. |
2. Sample Size and Data Provenance
- Test Set Sample Size: Forty-two (42) subject tattoos were initially enrolled, with forty-one (41) completing the study (1 lost to follow-up).
- Data Provenance: The study was a multicenter prospective clinical study. The country of origin is not explicitly stated in the provided text, but the FDA submission context suggests it was likely conducted in the US or in a manner compliant with US regulatory standards.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: A panel of independent, blinded reviewers (plural, implying more than one) was used. The exact number is not specified, but typically, panels consist of 3 or more experts.
- Qualifications of Experts: The experts were identified as "dermatologists." Further details on their years of experience or board certification are not provided in this summary.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly stated as a formal consensus or voting model (e.g., 2+1, 3+1). However, "Blinded review of baseline and post-treatment tattoo photographs resulted in a clinically and statistically significant mean improvement of..." suggests that the individual assessments of the blinded reviewers were aggregated and analyzed statistically (e.g., averaged) to produce the reported improvement scores rather than a strict adjudication for each case to reach a single consensus ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Yes, a comparative effectiveness study was performed. The study compared the "enlighten Laser System" (investigational device) against a "comparator Q-Switched Nd:YAG laser."
- Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: This metric is not applicable as the study was not evaluating an AI system or human-in-the-loop performance. It was a direct comparison of two laser devices, not an AI-assisted diagnostic or treatment planning tool. The "readers" here were medical dermatologists assessing photographic evidence of treatment outcome.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not done. The enlighten Laser System is a physical medical device (laser system) and its performance was assessed through a clinical study involving human patients and laser treatments administered by healthcare professionals, with outcomes assessed by human expert reviewers.
7. Type of Ground Truth Used
The ground truth for assessing efficacy was established through expert consensus (or aggregated expert assessment) of photographic evidence. Blinded dermatologists reviewed standardized photographs taken at baseline and 6 weeks post-final treatment to assess "tattoo clearing."
Safety ground truth was established by investigator assessments at each visit and through subject-reported phone surveys for adverse events.
8. Sample Size for the Training Set
The provided document describes a clinical study to assess the safety and efficacy of the enlighten Laser System. It does not mention any "training set" in the context of an algorithm or machine learning model. The study described is a clinical trial to evaluate the device itself.
9. How Ground Truth for the Training Set was Established
As there is no mention of an algorithm or machine learning component, there is no "training set" or ground truth establishment method for it described in this document. The clinical study served to validate the performance of the physical laser device.
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