(150 days)
The Theralase™ TLC-1000 Therapeutic Medical Laser System is indicated for adjunctive use in the temporary relief of pain associated with knee disorders with standard chiropractic practice.
The Theralase™ TLC-1000 Therapeutic Medical Laser System is a non-heating infrared lamp as defined in 21 CFR 890.5500. The TLC-1000 system is a precision medical device as wontion of a hand held portable multiple laser probe (5 x 905 NIR laser diodes and 4 x 660 visible red laser diodes) and a laser controller unit with a rechargeable battery.
Acceptance Criteria and Device Performance for Theralase™ TLC-1000 Therapeutic Medical Laser System
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Efficacy (Pain Relief) | Statistically significant difference in pain reduction (VAO scores) between active laser and sham laser groups. | p-value |
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.