(135 days)
The LaserTouchOne™ is a low level laser and electrical stimulation device. This combination of low level light and electrical stimulation provides symptomatic relief of chronic, intractable pain, and is indicated for adjunctive treatment of postsurgical and post-traumatic acute pain and for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
The LaserTouchOne™ device is a rechargeable hand-held pain therapy device. It combines the technology of low level laser and transcutaneous electrical nerve stimulation in one unit. The low level (cold) laser therapy is delivered with a single diode laser of
I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the LaserTouchOne™ device, primarily focusing on its intended use, device description, comparison to predicate devices, and the FDA's substantial equivalence determination. It does not include details about specific performance metrics, clinical trial design, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).