# K032816: Quantum Light Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Stargate International, Inc.
- Decided: Mar 26, 2004 after 199 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: 2 generations back to K001179 (2000). 3 ancestors in all.
73 later devices descend from it; 4 cite it directly.
0 of 77 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.
- K001179: Super Nova, Acubeam, Light Force Therapy, Inc. (2000)
- K020017: Medx 1000 Series, Medx Electronics, Inc. (2002) Summary page 2.

## Most influential descendants
- K091496: Mep-90 Hair Growth Stimulation System (2010), 58 descendants of its own
- K113097: Laser Helmet (2012), 57 descendants of its own
- K150613: LaserCap LC Pro and LC Elite (2015), 46 descendants of its own
- K122950: Laser Helmet (2013), 46 descendants of its own
- K153618: Capillus202 (2016), 44 descendants of its own

## Indications for use
The Quantum Light Therapy System is a non-heating lamp, infrared as described under the provisions of 21 CFR §890.5500 and is indicated for: Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin using the QS-2; QS-4; and/or the QS-L applicator heads.

Source page: https://510kreport.com/device/K032816
Methodology: https://510kreport.com/methodology