# K091675: Laserpen Practise and Expert, Handylaser Sprint, Handylaser Trion, Physiolaser Olympic, Polylaser

- Pathway: 510(k) (Traditional)
- Applicant: Reimers and Janssen GmbH
- Decided: Dec 15, 2009 after 189 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The RJ Low Level Laser are intended to emit energy in the infrared spectrum to provide topical heating for the purposes of elevating tissue temperature when heat is indicated for the temporary relief of minor muscle and joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, to temporarily increase local blood circulation where applied and the relaxation of muscles. This is a prescription only device.

Source page: https://510kreport.com/device/K091675
Methodology: https://510kreport.com/methodology