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510(k) Data Aggregation
(90 days)
a. while using the red and violet diode simultaneously, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin,
b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.
The Erchonia® EVRL (Model# EVRL) is a low-level laser system that uses two semi-conductor diodes (visible red and violet light), red: 630-650 nm and violet: 380-450 nm. The Erchonia® EVRL (Model# EVRL) is a variable hertz device. The variable hertz feature of the Erchonia® EVRL (Model# EVRL) is a pulsed wave, defined as containing a selected series of breaks, variances. The Erchonia® EVRL (Model# EVRL) has been classified by the FDA/EC as a Class II/IIa device and a Class II/2 laser.
The Erchonia® EVRL (Model# EVRL) is indicated for use:
a. while using the red and violet diode simultaneously, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin,
b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.
The Erchonia® Laser is applied externally and has proven through clinical trials to treat neck and shoulder pain with the red diode.
The components of the device consist of:
An ultra-slim hand-held battery-operated control device with a docking station providing two laser diodes a 640 nanometer and a 405 nanometer. Each laser diode emits its wavelength with a tolerance of ±10 nanometer. The lasers are powered by an internal battery that is recharged using a separate inductive charging base powered by an external class II medical power supply. This configuration offers portability as well as consistency of power.
The internal battery powers the two specially created and patented electronic diodes with an output of 7.5mW ± 1mW red and
The provided text describes a 510(k) premarket notification for the Erchonia® EVRL device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (the same model, K152196) and presents clinical data to support the device's expanded indication for use in relieving neck and shoulder pain.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this 510(k) submission appear to be centered around demonstrating non-inferiority or superiority of the Erchonia® EVRL when using both red and violet diodes simultaneously for neck and shoulder pain, compared to the previously cleared red diode only application.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Primary Outcome: Demonstrate that the Erchonia® EVRL with dual red/violet diode application achieves a similar or better percentage of individual subject successes (30% or greater decrease in Visual Analog Pain Scale (VAS) rating) compared to the 2001 active red diode only trial, with an overall study success criterion of 65% ± 5%. | Achieved: 75% of subjects in the current study attained individual success, exceeding the overall study success criteria by 5% and outperforming the 65.1% of actively treated subjects in the 2001 trial. |
| Secondary Outcome (Clinical Significance): Demonstrate a statistically significant reduction in neck and shoulder VAS pain rating from baseline to endpoint. | Achieved: A 29.80-point mean decrease in VAS pain rating was observed, which was found to be statistically significant at p |
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