# K050668: GRT Lite, Model 8-a

- Pathway: 510(k) (Traditional)
- Applicant: Grt Solutions, Inc.
- Decided: Feb 3, 2006 after 325 days
- Product code: NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K001179 (2000). 7 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012580: Erchonia PL2000, Tuco Innovations, Inc. (2002) Summary page 2.
- K041530: Excalibur Light Therapy System, Model Sgiex-04-001, Stargate International, Inc. (2004) Summary page 2.
- K010175: Microlight 830 Laser System, Microlight Corporation of America (2002) Summary page 2.
- K020657: Acculaser Pro Low Level Laser Therapy Device, Acculaser, Inc. (2002) Summary page 2.

## Most influential descendants
- K081141: Combocare 2000 (2008), 6 descendants of its own
- K083202: Combocare 2000 (2008), 2 descendants of its own
- K241057: Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) (2025), 1 descendant of its own
- K083822: Laser Touchone (2009), 1 descendant of its own
- K252273: Therapy US (2025), 0 descendants of its own

## Indications for use
The GRT Model PRO-8A is a non-heating lamp, infrared under the provisions of 21 CFR §890.5500 and its indications for use: Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin. Adjunctive use in providing temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome (CTS).

Source page: https://510kreport.com/device/K050668
Methodology: https://510kreport.com/methodology