(90 days)
Not Found
No
The description focuses on low-level laser and electrical stimulation technology, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is described as a "pain therapy device" that provides "symptomatic relief of chronic, intractable pain" and "adjunctive treatment of post-surgical and post-traumatic acute pain." These are therapeutic claims.
No
The device is described as a pain therapy device providing symptomatic relief of pain, not for diagnosing conditions.
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™ (OTC) device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "symptomatic relief of chronic, intractable pain," "adjunctive treatment of post-surgical and post-traumatic acute pain," and "temporary relief of minor chronic neck and shoulder pain." These are all therapeutic applications, not diagnostic ones.
- Device Description: The description details a device that uses low level laser and electrical stimulation applied externally to the body. This is consistent with a therapeutic device, not one that analyzes samples (like blood, urine, or tissue) which is characteristic of IVDs.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
In summary, the LaserTouchOne™ is a therapeutic device for pain relief, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LaserTouchOne™ (OTC) 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, NUH
Device Description
The LaserTouchOne™ (LTO) 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 (LLLT) 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
Submitter: Laser Health Technologies, LLC
:
LaserTouchOne™(OTC) Traditional 510(k)
510(k) SUMMARY— LaserTouchOne™(OTC)
| Submitter Name: | Laser Health Technologies, LLC |
|---|---|
| Submitter Address: | 10234 North 58 th Place |
| Paradise Valley, AZ 85253 | |
| Contact Person: | James Mantle, Manager |
'APR 1 5 2010
| Phone Number: | 602-821-1659 |
|---|---|
| Date Prepared: | January 12, 2010 |
| Device Trade Name: | LaserTouchOne™ (OTC) |
| Device Common Name: | Low level (cold) laser device and transcutaneous electrical nerve stimulator for pain therapy |
| Classification Numbers: | 21 CFR 890.5500; 21 CFR 882.5890 |
| Classification Names: | Non-heating lamp, for adjunctive use in pain therapy; |
| Transcutaneous electrical nerve stimulator, over-the-counter | |
| Product Codes: | NHN; NUH |
| Predicate Devices: | K083822, LaserTouchOne™; Laser Health Technologies, LLC |
| K080513; QLaser System; 2035, Inc. | |
| K063743; Rhythm Touch Q 2-Way, Shockim Enterprise Ltd. | |
| Statement of Intended Use: | The LaserTouchOne™ (OTC) 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. |
| Device Description: | The LaserTouchOne™ (LTO) 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 (LLLT) is delivered with a single diode laser of Sincerely yours Mark N. Melkerson |
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Submitter: Laser Health Technologies, LLC
510(k) Number (if known):
Device Name:
. ·· .
:
LaserTouchOne™(OTC)
Indications for Use:
The LaserTouchOne™(OTC) 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.
Prescription Use (Part 21 CFR 801 Subpart D)
(Posted November 13, 2003)
AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100116