# K134017: Gigalaser

- Pathway: 510(k) (Traditional)
- Applicant: Powermedic Aps
- Decided: May 2, 2014 after 123 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- 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: 9 generations back to K943450 (1995). 87 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070516: Powerlaser, Powermedic Aps (2007) Summary page 2.
- K030426: Omnilux Red, Photo Therapeutics Limited (2003) Summary page 2.

## Most influential descendants
- K142340: Infrared Therapy System (2014), 0 descendants of its own

## Indications for use
GIGALaser 1801 is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and for the temporary relaxation of muscles.

Source page: https://510kreport.com/device/K134017
Methodology: https://510kreport.com/methodology