# K083822: Laser Touchone

- Pathway: 510(k) (Traditional)
- Applicant: Laser Health Technologies, LLC
- Decided: May 6, 2009 after 135 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- 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: 6 generations back to K001179 (2000). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K822854: Pro Med 100, Rebco Trading Co. (1982) Summary page 1.
- K032816: Quantum Light Therapy System, Stargate International, Inc. (2004) Summary page 1.
- K081141: Combocare 2000, Xanacare Technologies, LLC (2008) Summary page 1.
- K883911: Electro-Acuscope 85, Biomedical Design Instruments (1990) Summary page 1.

## Most influential descendants
- K100116: Lasertouchone (Otc) (2010), 0 descendants of its own

## Indications for use
The LaserTouchOneTM 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/K083822
Methodology: https://510kreport.com/methodology