# K231997: SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)

- Pathway: 510(k) (Traditional)
- Applicant: Cure Point Therapeutics, Inc.
- Decided: Oct 15, 2024 after 468 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
Product Code ILY - 810 and 980 nm wavelength: The SIRONA 100 Therapy Laser System emits energy in the visible and near-infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle. Product Code PDZ - 980 nm wavelength: The SIRONA 100 Therapy Laser System is also indicated for use for the temporary increase of clear nail in patients with onychomycosis including dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.

Source page: https://510kreport.com/device/K231997
Methodology: https://510kreport.com/methodology