# K080689: Spectra Therapy System A1000 Laser Device

- Pathway: 510(k) (Traditional)
- Applicant: Premier Dynamics, Inc.
- Decided: Jul 9, 2008 after 120 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: 3 generations back to K974468 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043055: Terraquant MQ2000 Laser Therapy Device, Escada International, Inc. (2005) Summary page 1.

## Indications for use
The Spectra Therapy Spectra AIOOO is an infrared lamp intended to provide topical heating. The Spectra Therapy Spectra AlOOO is indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffuess, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

Source page: https://510kreport.com/device/K080689
Methodology: https://510kreport.com/methodology