# K063745: Medilaser, Model 1000

- Pathway: 510(k) (Traditional)
- Applicant: Laser Thera, LLC
- Decided: Apr 23, 2007 after 125 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Thor IR Lamp System: named in the summary without a submission number
- (no number) Super Nova: named in the summary without a submission number
- (no number) Acubeam systems: named in the summary without a submission number

## Indications for use
The MediLaser is an infrared lamp that is intended to emit energy in the 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, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.

Source page: https://510kreport.com/device/K063745
Methodology: https://510kreport.com/methodology