# K033923: TH0R Ddii IR Lamp System

- Pathway: 510(k) (Traditional)
- Applicant: Thor Intl.
- Decided: Mar 17, 2004 after 90 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
No predicates in its family tree.
109 later devices descend from it; 7 cite it directly.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Super Nova / Acubeam systems: named in the summary without a submission number
- (no number) BioFlex Professional Therapy System: named in the summary without a submission number

## Most influential descendants
- K070024: Thor VR Single Diode Laser Treatment Probe, Model 200 MW Single VR Diode Probe (2007), 77 descendants of its own
- K083595: Ezlase (2009), 58 descendants of its own
- K121286: EPIC 10 (2012), 31 descendants of its own
- K123971: Cynosure 1064NM Diode Laser (2013), 25 descendants of its own
- K170500: SIROLaser Advance+ (2017), 21 descendants of its own

## Indications for use
The THOR DDII IR Lamp System is intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.

Source page: https://510kreport.com/device/K033923
Methodology: https://510kreport.com/methodology