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510(k) Data Aggregation
(87 days)
Erchonia FX-635
The Erchonia® FX-635 laser is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.
The Erchonia® FX-635 (Model#: HPS) is low level laser system that uses three semi-conductor diodes (visible red-light) 630nm to 650mm. The Erchonia® FX-635 (Model#: HPS) is a variable hertz device. The variable hertz feature of the Erchonia® FX-635 (Model#: HPS) is a pulsed wave, defined as containing a selected series of breaks, variances that are preprogrammed. The Erchonia® FX 635 (Model#: HPS) has been classified by the FDA/EC as a Class II/Ila device and a Class II/2 Laser.
The Erchonia® FX 635, model: HPS laser is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain. The Erchonia® Laser is applied externally and has proven through clinical trials to treat the neck, shoulder, low back and plantar fasciitis.
The components of the device include a mobile base which plugs into the wall, using a hospital grade power cord, equipped with a medical grade transformer. The device runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to main power. Four (4) antistatic wheels that enable ease for maneuverability. A touch screen that functions as a display screen and input panel. The touch screen communicates with the PCB to initiate, stop or pause the energy flow to the laser diodes. The laser diodes can only be on or off; there is no user interface that allows the end user to alter the laser diode output. The low back protocol and heel pain protocol is factory set and cannot be altered by the end user. The device has an adjustable main arm that is attached to the mobile base with the laser head assembly located at the end. The adjustable main arm is capable to collapse into the mobile base for storage and transporting or extends to position the laser heads above the area of involvement. The laser head assembly that is attached to the adjustable main arm that is manually raised and lowered, utilizes internal mechanics that collects the light emitted from each of the three (3) laser diodes that rotate in a spiraling circle pattern that is totally random and independent of the other diodes. The laser head assembly is positioned 3-4 inches from the patient's skin to deliver treatment for pain. This assembly can be rotated 120 degrees for proper positioning to patient for accurate treatment. The laser head assembly includes arms and pivots that allow the three (3) laser output heads to be rotated, tilted, and raised / lowered independently. The device contains software that is loaded into the PCB drivers. This data includes the touch screen images (GUI) and the command prompts that activate the screen icons; work in conjunction with the component platform to ensure the device operates as intended.
The associated accessories include:
- Hospital grade power cord
- Patient protective eyewear
- Power safety lockout keys
1. A table of acceptance criteria and the reported device performance
| Clinical Endpoints | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pivotal Study 1 (K012580): Neck/Shoulder Pain | Primary Effectiveness Endpoint: | Primary Effectiveness Endpoint: |
| - Individual Subject Success | Defined as a 30% or greater improvement (decrease) in the primary efficacy measure (change in neck and shoulder pain rating on the 0-100 VAS) from baseline to endpoint. | 65.1% of actively treated subjects attained individual success. |
| - Study Success | Defined as a minimum 30% difference between treatment groups, comparing the proportion of individual successes. | A 53.5% difference between treatment groups was achieved, exceeding the 30% criteria by 23.5% (p |
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(117 days)
Erchonia FX-635
The Erchonia® FX-635 laser is indicated for the following two indications:
- a. as an adjunct to provide relief of minor chronic low back pain of musculoskeletal origin.
b. as an adjunct to reducing chronic heel pain arising from plantar fasciitis.
The Erchonia® FX-635 (Model#: HPS) is low level laser system that uses three semi-conductor diodes (visible red-light) 630nm to 650mm. The Erchonia® FX-635 (Model#: HPS) is a variable hertz device. The variable hertz feature of the Erchonia® FX-635 (Model#: HPS) is a pulsed wave, defined as containing a selected series of breaks, variances that are preprogrammed. The Erchonia® FX 635 (Model#: HPS) has been classified by the FDA/EC as a Class II/Ila device and a Class II/2 Laser. Erchonia® FX-635 (Model#: HPS) is indicated for use as an adjunct to provide relief of minor chronic low back pain of musculoskeletal origin. Erchonia® FX-635 (Model#: HPS) is also indicated for use as an adjunct to reducing chronic heel pain arising from plantar fasciitis.
The components of the device include a mobile base which plugs into the wall, using a hospital grade power cord, equipped with a medical grade transformer. The device runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to main power. Four (4) antistatic wheels that enable ease for maneuverability. A touch screen that functions as a display screen and input panel. The touch screen communicates with the PCB to initiate, stop or pause the energy flow to the laser diodes. The laser diodes can only be on or off; there is no user interface that allows the end user to alter the laser diode output. The low back protocol and heel pain protocol is factory set and cannot be altered by the end user, 20 minutes for providing relief of minor chronic low back pain of musculoskeletal origin, or 10 minutes for reducing chronic heel pain arising from plantar fasciitis, prior clearance K132940. The device has an adjustable main arm that is attached to the mobile base with the laser head assembly located at the end. The adjustable main arm is capable to collapse into the mobile base for storage and transporting or extends to position the laser heads above the area of involvement. The laser head assembly that is attached to the adjustable main arm that is manually raised and lowered, utilizes internal mechanics that collects the light emitted from each of the three (3) laser diodes that rotate in a spiraling circle pattern that is totally random and independent of the other diodes. The laser head assembly is positioned 3-4 inches from the patient's skin to deliver treatment for low back pain or treatment for heel pain. This assembly can be rotated 120 degrees for proper positioning to patient for accurate treatment. The laser head assembly includes arms and pivots that allow the three (3) laser output heads to be rotated, tilted, and raised / lowered independently. The device contains software that is loaded into the PCB drivers. This data includes the touch screen images (GUI) and the command prompts that activate the screen icons; work in conjunction with the component platform to ensure the device operates as intended.
The associated accessories include:
- Hospital grade power cord ●
- Patient protective eyewear
- Power safety lockout kevs .
The Erchonia® FX-635 laser is indicated as an adjunct to provide relief of minor chronic low back pain of musculoskeletal origin and as an adjunct to reducing chronic heel pain arising from plantar fasciitis.
Here's an analysis of the acceptance criteria and the study that supports it:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Success Measure for Low Back Pain Study) | Reported Device Performance (Low Back Pain Study) |
|---|---|
| Difference in proportion of subjects achieving ≥30% decrease in VAS pain rating between test and control groups was 35% or greater. | 72.4% of active group subjects attained a ≥30% decrease in low back pain VAS rating from baseline to endpoint, compared with 27.6% of placebo group subjects. This resulted in a 44.8% difference, which was statistically significant (p |
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