# K141564: Opton Pro

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Medizinsystems GmbH
- Decided: Oct 24, 2014 after 134 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: 7 generations back to K001179 (2000). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091497: K-Laser K-1200, Model 12 W, Eltech S.R.L (2009) Summary page 5.
- K040662: Vectra Genisys (Module & Transportable) and Intelect XT (Module & Transportable) Laser Systems, Chattanooga Group (2004) Summary page 5.

## Indications for use
• temporary relief of minor muscle and joint aches, pains and stiffness • temporary relief of muscle spasm • temporary relief of minor pain and stiffness associated with arthritis • promoting relaxation of the muscle tissue • temporary increase in local blood circulation

Source page: https://510kreport.com/device/K141564
Methodology: https://510kreport.com/methodology