(135 days)
Not Found
No
The description focuses on the physical technologies (low level laser and electrical stimulation) and does not mention any AI/ML components or capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "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." This description clearly indicates a therapeutic purpose.
No
The device is described as providing "symptomatic relief of chronic, intractable pain" and "adjunctive treatment" for pain. It combines low level laser and electrical stimulation for therapy, not for diagnosing conditions or diseases.
No
The device description explicitly states it is a "rechargeable hand-held pain therapy device" that combines "low level laser and transcutaneous electrical nerve stimulation in one unit," indicating it is a physical hardware device.
Based on the provided information, the LaserTouchOne™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for symptomatic relief of pain and adjunctive treatment of pain. This is a therapeutic use, not a diagnostic one.
- Device Description: The device applies low level laser and electrical stimulation to the body. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The LaserTouchOne™ does not fit this description.
N/A
Intended Use / Indications for Use
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 post-surgical and post-traumatic acute pain and for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
Product codes
NHN, GZJ
Device Description
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
§ 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).
0
6083822
510(k) SUMMARY- LaserTouchOne™
Submitter Name: Laser Health Technologies, LLC
Submitter Address: 10234 North 58$^{th}$ Place
Paradise Valley, AZ 85253
Contact Person: James Mantle, Manager
Phone Number: 602-821-1659
Date Prepared: April 21, 2009
Device Trade LaserTouchOne™
Name:
Device Common Low level (cold) laser device (LLLT) and transcutaneous
Name: electrical nerve stimulator (TENS) for pain therapy
Classification 21 CFR 890.5500; 21 CFR 882.5890
Numbers:
Classification Non-heating lamp, for adjunctive use in pain therapy;
Names: Transcutaneous electrical nerve stimulator
Product Codes: NHN; GZJ
Predicate Devices: Rebco Trading Co., Pro Med 100 (K822854)
Stargate International, Inc., Quantum Light Therapy System
(K032816)
Xanacare Technologies, Inc., ComboCare 2000 (K081141)
Biomedical Design Instrumments, Electro-Acuscope 85
(K883911)
Statement of The LaserTouchOne™ is a low level laser and electrical
Intended Use: 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
post-surgical and post-traumatic acute pain and for adjunctive
use in providing temporary relief of minor chronic neck and
shoulder pain of musculoskeletal origin.
MAY - 6 2009
1
The LaserTouchOne™ device is a rechargeable hand-held pain Device Description: 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