(344 days)
The LightStream Low Level Laser device is indicated for adjunctive use in the temporary relief of pain associated with knee disorders with standard chiropractic practice.
The LightStream Laser is a handheld, non-invasive, low energy, non thermal infrared therapeutic medical laser. The LightStream Laser System incorporates an AC or battery powered Control Unit and a hand-held laser diode probe with one laser tip and one cluster probe with 5 laser tips. The device incorporate Gallium Aluminum Arsenide (GaAlAs) laser diodes delivering 60mW at the 903 nanometer (nm) wavelength, classifying it under under 21 CFR 890.5500, NHN as non-heating infrared lamp for adjunctive use in pain therapy. The LightStream is a non thermal device and is intended to be for adjunctive use in pain therapy and is not intended to provide therapeutic topical heating.
The provided text describes the Solica Corp LightStream Laser, but it does not contain any information about acceptance criteria or a study proving the device meets specific performance criteria related to its therapeutic effectiveness for pain relief.
Instead, the document focuses on:
- Device Description: What the LightStream Laser is, its technical specifications (e.g., wavelength, power), and its classification.
- Intended Use: For adjunctive use in the temporary relief of pain associated with knee disorders with standard chiropractic practice.
- Predicate Device Comparison: Establishing substantial equivalence to an already cleared device (Theralase Inc. Theralase TLC-100) based on intended use and technological characteristics.
- Safety and Performance Testing: Compliance with general safety, EMC, and medical laser equipment standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22). These are engineering/electrical/safety standards, not clinical performance acceptance criteria for pain relief.
- Regulatory Clearance: The FDA's 510(k) clearance letter confirming substantial equivalence to the predicate device.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and a study proving therapeutic effectiveness because that information is not present in the provided text.
The document states that "Safety and performance testing was performed... The testing has demonstrated that the device complies with both safety and performance FDA recognized consensus standards that apply to the LightStream Low Level Laser." However, these "performance" standards refer to technical performance (e.g., laser output, electrical safety) rather than clinical performance (e.g., efficacy in pain reduction). The clearance is based on substantial equivalence to a predicate device, which implies that if the predicate device was safe and effective for its intended use, a substantially equivalent new device would also be. There's no clinical trial data described for the LightStream Low Level Laser itself to establish unique acceptance criteria for pain relief efficacy.
§ 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.