# K100116: Lasertouchone (Otc)

- Pathway: 510(k) (Traditional)
- Applicant: Laser Health Technologies, LLC
- Decided: Apr 15, 2010 after 90 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001179 (2000). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083822: Laser Touchone, Laser Health Technologies, LLC (2009) Summary page 1.
- K080513: Qlaser System, 2035, Inc. (2009) Summary page 1.
- K063743: Rhythm Touch Q 2-Way, Shockim Enterprises, Ltd. (2007) Summary page 1.

## 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.

Source page: https://510kreport.com/device/K100116
Methodology: https://510kreport.com/methodology